Der skeete en masse igår
først og fremmest fremlagde firmaet deres resultater for Provenge IMPACT studiet - som mødte alle endpoints, og krav fra FDA -samt viste en overlevelse på 4,3 længere, hvor kemo'en der benyttes som 1. valg i behandling i øjeblikket kun er på 2,3
og der er jo enorm forskel på bivirknings profilen, hvor provenge har få små eller ingen bivirkninger og kemoen mange og store.
så Girls and Boys - Imunterapi - kan blive vor tids "kemo"
og det forventes at Provenge blir godkendt af FDA, hvor det så vil have Blockbuster potientiale indtjeningsmæssigt.
Lige før aktien blev haltet var der et drop i kursen på 45% - fordi nogen af shorterne droppede 800000 aktier på no time, hvorefer det lykkedes dem at nuppe 3 mill billige aktier på automatiske SL
det var jo et genialt trick - når man påtænker at der igår var 23 % short i aktien - selvom alle forventede great news
Firmaet forventer selv at stå for salg i US, samt at finde en ROW partner til europa og resten af verden - der er stor interesse sagde de på konferencen - men intet er afklaret endnu.
Jeg ligger fortsat long - og holder - og er forberedt på at kursen kan svinge voldsomt den næste tid -
og jeg vil øge hvis kursen når ned omk 17
Ha en god dag
Hya
DNDN research blog updated
Business Week on AUA
http://tinyurl.com/ddbrn4
NY Times on AUA
http://tinyurl.com/d5tlda
Seattle Times on AUA
http://tinyurl.com/dfc5om
Reuters on AUA
http://tinyurl.com/csenqk
Forbes with the usual FUD on AUA
http://tinyurl.com/cf4grh
Wall Street Journal
http://tinyurl.com/cc98sm
David Miller on the AUA:
http://tinyurl.com/d6of4t
A view from a urologist on the AUA results:
http://tinyurl.com/dhp9yq
Ocyan take on the IMPACT results on 4/28 PR
http://tinyurl.com/dzqufl
And then summarized the AUA slides
http://tinyurl.com/che5fs
http://dndninfo.blogspot.com/
først og fremmest fremlagde firmaet deres resultater for Provenge IMPACT studiet - som mødte alle endpoints, og krav fra FDA -samt viste en overlevelse på 4,3 længere, hvor kemo'en der benyttes som 1. valg i behandling i øjeblikket kun er på 2,3
og der er jo enorm forskel på bivirknings profilen, hvor provenge har få små eller ingen bivirkninger og kemoen mange og store.
så Girls and Boys - Imunterapi - kan blive vor tids "kemo"
og det forventes at Provenge blir godkendt af FDA, hvor det så vil have Blockbuster potientiale indtjeningsmæssigt.
Lige før aktien blev haltet var der et drop i kursen på 45% - fordi nogen af shorterne droppede 800000 aktier på no time, hvorefer det lykkedes dem at nuppe 3 mill billige aktier på automatiske SL
det var jo et genialt trick - når man påtænker at der igår var 23 % short i aktien - selvom alle forventede great news
Firmaet forventer selv at stå for salg i US, samt at finde en ROW partner til europa og resten af verden - der er stor interesse sagde de på konferencen - men intet er afklaret endnu.
Jeg ligger fortsat long - og holder - og er forberedt på at kursen kan svinge voldsomt den næste tid -
og jeg vil øge hvis kursen når ned omk 17
Ha en god dag
Hya
DNDN research blog updated
Business Week on AUA
http://tinyurl.com/ddbrn4
NY Times on AUA
http://tinyurl.com/d5tlda
Seattle Times on AUA
http://tinyurl.com/dfc5om
Reuters on AUA
http://tinyurl.com/csenqk
Forbes with the usual FUD on AUA
http://tinyurl.com/cf4grh
Wall Street Journal
http://tinyurl.com/cc98sm
David Miller on the AUA:
http://tinyurl.com/d6of4t
A view from a urologist on the AUA results:
http://tinyurl.com/dhp9yq
Ocyan take on the IMPACT results on 4/28 PR
http://tinyurl.com/dzqufl
And then summarized the AUA slides
http://tinyurl.com/che5fs
http://dndninfo.blogspot.com/
Hej Hya....kan du også give en update på short ratioen??
Måske vil jeg forsøge at gå ind i den idag...
Måske vil jeg forsøge at gå ind i den idag...
29/4 2009 18:52 cyber 0
9408 Brean Murray Carret & Co.'s Jonathan Aschoff raising DNDN to a "Buy" with a $35 price target.
http://www.cnbc.com/id/30475951/site/14081545?__source=yahoo%7Cheadline%7Cquote%7Ctext%7C&par=yahoo
http://www.cnbc.com/id/30475951/site/14081545?__source=yahoo%7Cheadline%7Cquote%7Ctext%7C&par=yahoo
29/4 2009 19:45 Hya 09413 http://www.level2stockquotes.com/level-ii-quotes.html
der kan man følge level 2 live
igår før tradestop var der 23% short i aktien
og idag ligger mange optioner skævt i forhold til kursen
tik tik mon vi snart kan lave en vw stigning når short'erne får margincalls samtidig med at institunelle vil positionere sig long
der er optionsudløb den 9 maj
volumen under handlen idag viser da for enhver at der manipuleres groft med kursen
mineaktier er relle og slet ikke til salg på disse niveauer.
Hya
der kan man følge level 2 live
igår før tradestop var der 23% short i aktien
og idag ligger mange optioner skævt i forhold til kursen
tik tik mon vi snart kan lave en vw stigning når short'erne får margincalls samtidig med at institunelle vil positionere sig long
der er optionsudløb den 9 maj
volumen under handlen idag viser da for enhver at der manipuleres groft med kursen
mineaktier er relle og slet ikke til salg på disse niveauer.
Hya
29/4 2009 19:56 fistandanti 09415 Superb aktie!
Positivt at skeptikerne efterhånden også er blevet overbeviste; at gå fra et kurstarget på 1 op til 35 dollars, er noget der batter!!
Jeg beholder stadig mine, ikke solgte en eneste og tværtimod supplerede jeg i 19-lejet lidt over uge siden.
Det bliver spændende at følge DNDNs bevægelser op til FDAs forhåbentlige approval.
Positivt at skeptikerne efterhånden også er blevet overbeviste; at gå fra et kurstarget på 1 op til 35 dollars, er noget der batter!!
Jeg beholder stadig mine, ikke solgte en eneste og tværtimod supplerede jeg i 19-lejet lidt over uge siden.
Det bliver spændende at følge DNDNs bevægelser op til FDAs forhåbentlige approval.
29/4 2009 20:29 fistandanti 09417 En god artikel.
http://www.thestreet.com/story/10493628/4/dendreons-provenge-a-behind-the-scenes-look.html
http://www.thestreet.com/story/10493628/4/dendreons-provenge-a-behind-the-scenes-look.html
30/4 2009 00:37 Hya 09465 Wall Street Journal, Tom Gryta Dendreon article LINK
APRIL 29, 2009, 1:06 P.M. ET
Dendreon Drug Clears Difficult Hurdle, But Others Remain
By Thomas Gryta
Of DOW JONES NEWSWIRES
NEW YORK (Dow Jones)--Dendreon Corp. (DNDN) has cleared a significant hurdle in bringing its controversial prostate cancer treatment Provenge to market, but obstacles remain before the drug gets launched.
Provenge could be a blockbuster drug, with the potential to revolutionize cancer treatment by harnessing the immune system to fight the disease, but the Seattle drug developer still must pass a cautious Food and Drug Administration, including the resolution of manufacturing questions.
Dendreon also could face resistance over the drug's price at a time when the government is looking to reduce healthcare costs. Though they will likely cover the drug, insurers may make noise about paying high sums for a treatment that may only add a few months to a patient's life.
These issues, along with a likely healthy short interest position, could lead to continued volatility for the excitable stock.
Today, though, the emphasis is on the positive as Dendreon shares recently more than doubled to $24.12 in heavy trading, likely wiping out some short positions. Earlier, the stock hit an all-time high of $27.40. Part of Dendreon's new valuation may reflect the company's potential to secure a lucrative partnership or outright acquisition.
On Tuesday, data showed that Provenge prolonged the lives of advanced prostate-cancer patients by 4.1 months, likely meeting targets set under a special agreement with the FDA in 2007, when the agency said it wanted to see the results before deciding whether to approve Provenge.
"This is an execution story now," said analyst Joe Pantginis with Merriman Curhan Ford.
Following the Provenge data, many analysts now have price targets of more than $30 for the stock based on future annual sales rising up to $2 billion. But analyst models don't include the possibility of off-label sales, which could be significant as physicians may use the drug in earlier-stage patients because of its mild side effects in comparison to toxic chemotherapy regimens.
The next step for Dendreon will be to file its amendment to a previously rejected marketing application for Provenge in the fourth quarter. Opinions remain split on whether the Food and Drug Administration will want to hold an advisory panel to review the new data.
Some believe that Dendreon's conversations with regulators made it clear that its latest trial will be enough for approval, but others maintain that the FDA will seek maximum input in approving a new class of drugs.
The FDA also must approve Dendreon's New Jersey manufacturing facility, which prompted agency questions in its previous marketing application. Dendreon has said it "substantially responded" to those issues, but the final word will come from the agency.
Unlike making a pill, Provenge's production involves taking a patient's cells, shipping them to the company for processing, then returning them to a physician to be delivered via intravenous infusion. This entire process must be performed three times over four weeks.
The FDA may proceed with caution in overseeing this new type of production, but many note that Provenge's production for clinical trials has allowed Dendreon to work out any major issues.
The company expects Provenge to be priced similarly to other biologic medicines that have complicated manufacturing processes. Those drugs, like Roche Holding AG's (RHHBY) Avastin, can sell for more than $50,000 a year.
The acceptance of high-priced biologic drugs by insurers has observers confident that Provenge should have no problem getting the support of those that pay for patient treatment.
Dendreon will clearly face costs in launching Provenge, but many expect that its cash position of $105 million in cash and short-term investment at Dec. 31 to be sufficient. No longer having to pay for the expensive late-stage clinic trial should significantly cut expenses.
Dendreon expects to sell the drug in the U.S. but find a partner for overseas marketing. Having a strong cash position, in the currently difficult funding environment, will likely allow Dendreon to negotiate better partnership terms because it doesn't need a cash injection.
Pantginis believes that Takeda Pharmaceuticals Co. (4502.TO), GlaxoSmithKline Plc (GSK) and Sanofi-Aventis (SNY) are the most likely partners because of their interest in cancer immunotherapy.
Furthermore, it is possible that partnership talks could develop into an outright acquisition of Dendreon.
The prospect of an unpartnered cancer drug with strong data from a company with a platform that could produce future pipeline candidates may be too good for suitors to pass up - especially as Dendreon still only has a market value of $2.3 billion.
Last year, Eli Lilly & Co (LLY) paid $6.5 billion for ImClone Systems, citing its attractive pipeline of biologic cancer therapies, even though ImClone's only product, cancer drug Erbitux, was already partnered with Bristol-Myers Squibb Co. (BMY).
http://online.wsj.com/article/BT-CO-20090429-716237.html-Thomas Gryta; Dow Jones Newswires; 201-938-2053; thomas.gryta@dowjones.com
APRIL 29, 2009, 1:06 P.M. ET
Dendreon Drug Clears Difficult Hurdle, But Others Remain
By Thomas Gryta
Of DOW JONES NEWSWIRES
NEW YORK (Dow Jones)--Dendreon Corp. (DNDN) has cleared a significant hurdle in bringing its controversial prostate cancer treatment Provenge to market, but obstacles remain before the drug gets launched.
Provenge could be a blockbuster drug, with the potential to revolutionize cancer treatment by harnessing the immune system to fight the disease, but the Seattle drug developer still must pass a cautious Food and Drug Administration, including the resolution of manufacturing questions.
Dendreon also could face resistance over the drug's price at a time when the government is looking to reduce healthcare costs. Though they will likely cover the drug, insurers may make noise about paying high sums for a treatment that may only add a few months to a patient's life.
These issues, along with a likely healthy short interest position, could lead to continued volatility for the excitable stock.
Today, though, the emphasis is on the positive as Dendreon shares recently more than doubled to $24.12 in heavy trading, likely wiping out some short positions. Earlier, the stock hit an all-time high of $27.40. Part of Dendreon's new valuation may reflect the company's potential to secure a lucrative partnership or outright acquisition.
On Tuesday, data showed that Provenge prolonged the lives of advanced prostate-cancer patients by 4.1 months, likely meeting targets set under a special agreement with the FDA in 2007, when the agency said it wanted to see the results before deciding whether to approve Provenge.
"This is an execution story now," said analyst Joe Pantginis with Merriman Curhan Ford.
Following the Provenge data, many analysts now have price targets of more than $30 for the stock based on future annual sales rising up to $2 billion. But analyst models don't include the possibility of off-label sales, which could be significant as physicians may use the drug in earlier-stage patients because of its mild side effects in comparison to toxic chemotherapy regimens.
The next step for Dendreon will be to file its amendment to a previously rejected marketing application for Provenge in the fourth quarter. Opinions remain split on whether the Food and Drug Administration will want to hold an advisory panel to review the new data.
Some believe that Dendreon's conversations with regulators made it clear that its latest trial will be enough for approval, but others maintain that the FDA will seek maximum input in approving a new class of drugs.
The FDA also must approve Dendreon's New Jersey manufacturing facility, which prompted agency questions in its previous marketing application. Dendreon has said it "substantially responded" to those issues, but the final word will come from the agency.
Unlike making a pill, Provenge's production involves taking a patient's cells, shipping them to the company for processing, then returning them to a physician to be delivered via intravenous infusion. This entire process must be performed three times over four weeks.
The FDA may proceed with caution in overseeing this new type of production, but many note that Provenge's production for clinical trials has allowed Dendreon to work out any major issues.
The company expects Provenge to be priced similarly to other biologic medicines that have complicated manufacturing processes. Those drugs, like Roche Holding AG's (RHHBY) Avastin, can sell for more than $50,000 a year.
The acceptance of high-priced biologic drugs by insurers has observers confident that Provenge should have no problem getting the support of those that pay for patient treatment.
Dendreon will clearly face costs in launching Provenge, but many expect that its cash position of $105 million in cash and short-term investment at Dec. 31 to be sufficient. No longer having to pay for the expensive late-stage clinic trial should significantly cut expenses.
Dendreon expects to sell the drug in the U.S. but find a partner for overseas marketing. Having a strong cash position, in the currently difficult funding environment, will likely allow Dendreon to negotiate better partnership terms because it doesn't need a cash injection.
Pantginis believes that Takeda Pharmaceuticals Co. (4502.TO), GlaxoSmithKline Plc (GSK) and Sanofi-Aventis (SNY) are the most likely partners because of their interest in cancer immunotherapy.
Furthermore, it is possible that partnership talks could develop into an outright acquisition of Dendreon.
The prospect of an unpartnered cancer drug with strong data from a company with a platform that could produce future pipeline candidates may be too good for suitors to pass up - especially as Dendreon still only has a market value of $2.3 billion.
Last year, Eli Lilly & Co (LLY) paid $6.5 billion for ImClone Systems, citing its attractive pipeline of biologic cancer therapies, even though ImClone's only product, cancer drug Erbitux, was already partnered with Bristol-Myers Squibb Co. (BMY).
http://online.wsj.com/article/BT-CO-20090429-716237.html-Thomas Gryta; Dow Jones Newswires; 201-938-2053; thomas.gryta@dowjones.com
30/4 2009 13:03 Hya 09536 Seeking Alpha...Dendreon: What Happened on April 28th? ....
http://seekingalpha.com/article/134187-dendreon-what-happened-on-april-28th?source=yahoo
.
All Dendreon (DNDN) longs almost had a heart attack when they saw the stock fall (I should even say CRASH) from the 24-25 level to 7-8 in less than 2 minutes to finally close at 11.86 before the stock was suspended for pending news (I bet the suspension appeared at an earlier time than expected due to this huge fall). The volume during this fall was huge (around 4-5 millions shares).
.
But then yesterday, the stock opened at 25+ and (at the time of writing) was trading around this level.
So what happened? Before giving the different scenarios that I see, it would be fair to explain the background on the stock.
.
Dendreon was expected to annonce major data about their IMPACT study concerning their "revolutionary" product at 2pm ET. The stock jumped from $2.5 (in early March) to $24 before the data release (most of the gains appeared in the last 15 days). Now before the big jump due to the pre-release on April 15, Dendredon was trading within a range between $5 and $10. The stock was (and still is) heavy shorted. This accounts to over 20% of the total shares, and if you exclude institutional and insider ownership, you arrive at a huge 50% of floating share. We can assume that most shorted shares were done so under $20 a share. So with the stock at $24 before the news release, all shorts were losing money. So Dendreon was clearly a fight between shorts and longs. And for a very rare time lately in this market, the longs were winning the fight.
.
Now let's get back to the famous 1:25 pm to 1:27 pm trading period. What happened? I see several scenarios (PURE speculation on my part):
.
1) A large shareholder or group of shareholders that owns a lot of shares expected major news, and used their positions to pull down the stock (and activate all the stop loss which explains the quick fall) in order to fill their portfolio of stocks at a lower price. I see this possibility as very unlikely because that would have opened for the shorts an opportunity to cover with minimum loss or even, for some, little profit.
.
2) Shorts that were under water before the trade tried to trigger the stop loss (the same way as the potential big shareholders above would have done) in order to cover their shorts on the stop loss they activated. That would allow them to limit their lost. I do think this scenario is very possible. Only shorts wanted the stock to fall that low and only the shorts see major advantage to having a very low closing price (which would limit the upside after the good news). Imagine the short loss if the stock had to react on the huge data home run of DNDN if the stock was at $25 at the close?
.
Now here are the questions:
Will the SEC investigate? I hope so, but I don't believe they will just because they did nothing after the Bear Stearns or Lehman collapse, so why would they find something on a stock where longs (those that had no stop loss) still win too?
.
Why did Nasdaq keep the trade? I think that Nasdaq found out that only small investors (with their stop loss) got hit and big investors that were short limited their loss so they didn't bother to cancel the trade because they didn't see any reason to help the small investor :) (It sounds possible no?)
.
What's next? Even if shorts have been able to cover some of their positions on this trade, there is still a huge amount of shorts on the stock and ALL OF THEM are underwater because the stock is at an all time high. Therefore, it is a game of patience for the longs because shorts will have to cover sooner or later. A probable short squeeze should occur within hours or days. Just be patient, longs.
.
And what about the long term? I guess that the long term of Dendreon looks bright with the potential of their new system of treatment around Provenge. It could be a "smaller" Genentech (DNA) story and therefore the upside is huge. It could be a very good long term bet in the biotech sector.
.
Disclosure: Author holds a long position in Dendreon
-------------
Yesterday's manipulation....
I thought I would update you folks on my request to authorities to investigate the trading debacle before the trading stop.
I must be extremely vague on this and for this I'm am sorry. I have been told that a serious investigation has started. By whom, for what, et al... I can not say. But the investigation team requested complete and untainted confidentiality in order to expedite their investigation. Specifically, several of us requested a cross-jurisdiction investigation so that ALL parties culpable, be they regulators or administrators over the corrupt system be called into account.
Let's just say this... during the last 2 years, some of the DNDN board members approached me off and on about their various contacts within the various overseers of the business worlds. Those contacts were notified with our understanding of the facts. This ultimately may go in front of all 3 branches of the US Government at very high levels.
Today, I received confirmation that resources will be brought into the complaint to ascertain the real facts.
Like you, we hope for justice. I will do my utmost to aid you folks that lost money.
Please do not try to ask me for more information. I just wanted to let those who lost significant amounts of value to know that this situation will definitely be fully investigated.
If such authorities need your names, addresses and ask me to provide the information, I will publish specific information on how to be in contact with this group of investigators. As for now, let's let them gather the facts, officially.
I'm sorry I can't do more for all of you that lost so much money. I will continue to do my best to get those that can address your losses our deepest and strongest concerns.
Please know that there were several of us working behind the scenes to get the highest levels of our Government concerned. In many cases, we were not victims of this scheme, yet, we have been profoundly shaken by your losses. It is in all of our interests to pursue this action.
Good luck, my fellow investors.
Fordwill1953
-----------
samtidig med at Patrik Burne har samlet "beviser" gennem lang tid omkring kursmanipulationerne i bl a DNDN
så tror jeg på at der nu sker noget effektivt - for det drop var da for synligt!
Hya
http://seekingalpha.com/article/134187-dendreon-what-happened-on-april-28th?source=yahoo
.
All Dendreon (DNDN) longs almost had a heart attack when they saw the stock fall (I should even say CRASH) from the 24-25 level to 7-8 in less than 2 minutes to finally close at 11.86 before the stock was suspended for pending news (I bet the suspension appeared at an earlier time than expected due to this huge fall). The volume during this fall was huge (around 4-5 millions shares).
.
But then yesterday, the stock opened at 25+ and (at the time of writing) was trading around this level.
So what happened? Before giving the different scenarios that I see, it would be fair to explain the background on the stock.
.
Dendreon was expected to annonce major data about their IMPACT study concerning their "revolutionary" product at 2pm ET. The stock jumped from $2.5 (in early March) to $24 before the data release (most of the gains appeared in the last 15 days). Now before the big jump due to the pre-release on April 15, Dendredon was trading within a range between $5 and $10. The stock was (and still is) heavy shorted. This accounts to over 20% of the total shares, and if you exclude institutional and insider ownership, you arrive at a huge 50% of floating share. We can assume that most shorted shares were done so under $20 a share. So with the stock at $24 before the news release, all shorts were losing money. So Dendreon was clearly a fight between shorts and longs. And for a very rare time lately in this market, the longs were winning the fight.
.
Now let's get back to the famous 1:25 pm to 1:27 pm trading period. What happened? I see several scenarios (PURE speculation on my part):
.
1) A large shareholder or group of shareholders that owns a lot of shares expected major news, and used their positions to pull down the stock (and activate all the stop loss which explains the quick fall) in order to fill their portfolio of stocks at a lower price. I see this possibility as very unlikely because that would have opened for the shorts an opportunity to cover with minimum loss or even, for some, little profit.
.
2) Shorts that were under water before the trade tried to trigger the stop loss (the same way as the potential big shareholders above would have done) in order to cover their shorts on the stop loss they activated. That would allow them to limit their lost. I do think this scenario is very possible. Only shorts wanted the stock to fall that low and only the shorts see major advantage to having a very low closing price (which would limit the upside after the good news). Imagine the short loss if the stock had to react on the huge data home run of DNDN if the stock was at $25 at the close?
.
Now here are the questions:
Will the SEC investigate? I hope so, but I don't believe they will just because they did nothing after the Bear Stearns or Lehman collapse, so why would they find something on a stock where longs (those that had no stop loss) still win too?
.
Why did Nasdaq keep the trade? I think that Nasdaq found out that only small investors (with their stop loss) got hit and big investors that were short limited their loss so they didn't bother to cancel the trade because they didn't see any reason to help the small investor :) (It sounds possible no?)
.
What's next? Even if shorts have been able to cover some of their positions on this trade, there is still a huge amount of shorts on the stock and ALL OF THEM are underwater because the stock is at an all time high. Therefore, it is a game of patience for the longs because shorts will have to cover sooner or later. A probable short squeeze should occur within hours or days. Just be patient, longs.
.
And what about the long term? I guess that the long term of Dendreon looks bright with the potential of their new system of treatment around Provenge. It could be a "smaller" Genentech (DNA) story and therefore the upside is huge. It could be a very good long term bet in the biotech sector.
.
Disclosure: Author holds a long position in Dendreon
-------------
Yesterday's manipulation....
I thought I would update you folks on my request to authorities to investigate the trading debacle before the trading stop.
I must be extremely vague on this and for this I'm am sorry. I have been told that a serious investigation has started. By whom, for what, et al... I can not say. But the investigation team requested complete and untainted confidentiality in order to expedite their investigation. Specifically, several of us requested a cross-jurisdiction investigation so that ALL parties culpable, be they regulators or administrators over the corrupt system be called into account.
Let's just say this... during the last 2 years, some of the DNDN board members approached me off and on about their various contacts within the various overseers of the business worlds. Those contacts were notified with our understanding of the facts. This ultimately may go in front of all 3 branches of the US Government at very high levels.
Today, I received confirmation that resources will be brought into the complaint to ascertain the real facts.
Like you, we hope for justice. I will do my utmost to aid you folks that lost money.
Please do not try to ask me for more information. I just wanted to let those who lost significant amounts of value to know that this situation will definitely be fully investigated.
If such authorities need your names, addresses and ask me to provide the information, I will publish specific information on how to be in contact with this group of investigators. As for now, let's let them gather the facts, officially.
I'm sorry I can't do more for all of you that lost so much money. I will continue to do my best to get those that can address your losses our deepest and strongest concerns.
Please know that there were several of us working behind the scenes to get the highest levels of our Government concerned. In many cases, we were not victims of this scheme, yet, we have been profoundly shaken by your losses. It is in all of our interests to pursue this action.
Good luck, my fellow investors.
Fordwill1953
-----------
samtidig med at Patrik Burne har samlet "beviser" gennem lang tid omkring kursmanipulationerne i bl a DNDN
så tror jeg på at der nu sker noget effektivt - for det drop var da for synligt!
Hya
30/4 2009 13:08 Hya 09537 og her er en mere
I have seen this kind of market action before. See MELA on Fwb. 4 - 5 when the stock plunged from over 5 to a low of 3 on huge volume and no news. A couple days later positive news sent the stock over 7. See RMBS on April 20, 2006 when the stock plunged from 46 to 29 on vague rumers of an unfavorable jury ruling. Shortly later a positive verdict was released.
The manipulation strategy is pretty simple. Find a stock that is expecting major news shortly. Wait for the stock buying to dry up and then flood the stock and option (call) markets with sell orders to take out the stop loss positions and panic momentum traders and weak holders. Then, try to cover (or rebuy) at the reduced prices. I am not sure that there is anything illegal about this. There is no need for insider information. In fact, the strategy works best if the news is highly likely to be positive, so that profits are made by buying (covering) at the suppressed price.
I have seen this kind of market action before. See MELA on Fwb. 4 - 5 when the stock plunged from over 5 to a low of 3 on huge volume and no news. A couple days later positive news sent the stock over 7. See RMBS on April 20, 2006 when the stock plunged from 46 to 29 on vague rumers of an unfavorable jury ruling. Shortly later a positive verdict was released.
The manipulation strategy is pretty simple. Find a stock that is expecting major news shortly. Wait for the stock buying to dry up and then flood the stock and option (call) markets with sell orders to take out the stop loss positions and panic momentum traders and weak holders. Then, try to cover (or rebuy) at the reduced prices. I am not sure that there is anything illegal about this. There is no need for insider information. In fact, the strategy works best if the news is highly likely to be positive, so that profits are made by buying (covering) at the suppressed price.
30/4 2009 13:20 JørgenVarnæs 09541 hvis SEC mener det alvorligt med at beskytte den almindelige investor, der arbejder seriøst med stop-loss og langsigtede strategier, så skal de fandenbankemig komme op af stolen. Det her ødelægger jo tilliden til markedet totalt.
Det svarer jo lidt til organiseret kriminalitet med disse angreb på ellers fornuftige virksomheder.
Interessant case hya - og interessant test af SEC. Glæder mig til at se, hvad der sker/ikke sker herfra.
mvh JV
Det svarer jo lidt til organiseret kriminalitet med disse angreb på ellers fornuftige virksomheder.
Interessant case hya - og interessant test af SEC. Glæder mig til at se, hvad der sker/ikke sker herfra.
mvh JV
1/5 2009 18:45 Hya 09744 A Layman's History of Provenge
Below is an essay I posted on my political weblog this morning regarding the history of Provenge. It is surely too ‘elementary’ for many here on this forum, but I wanted it to be easily understood by readers who are not familiar with Dendreon.
I am nowhere near as knowledgeable as many on this board regarding the scientific facts and figures involved in Provenge’s development and potential. For those who have the time and inclination to read it, I would appreciate any additions, corrections, constructive criticisms. TIA.
Anatomy of an Ambush
About five years ago I began following a small biotech company called Dendreon. I did a great deal of research on the company and began corresponding with people -- urologists, oncologists, researchers and clinicians -- who knew much more than I about the products in their pipeline, the process through which one must move in order to obtain FDA approval, and the conceivable potential of the vaccines that Dendreon was developing.
I became convinced that this company had several blockbuster products in its pipeline, so I purchased shares of the stock, continued to read experts’ opinions, and kept my ear open for developments, both positive and negative.
At the time, Dendreon’s most promising product, which appeared closest to FDA approval, was an anti-prostate cancer vaccine called Provenge. But following closely behind was a second vaccine -- this one for breast cancer -- called Neuvenge. Both vaccines concentrate on one antigen and a revolutionary cassette technology that has the potential to be a powerful tool in confronting many types of cancer. The development of the second vaccine had been sidelined for years due to financial concerns. A small fledgling biotech company is not awash in cash.
The current most common treatment for advanced stage prostate cancer is a chemotherapy treatment called Taxotere, whose side-effects can be torturous – some of which include: low levels of white blood cells, anemia, hair loss, mouth sores, severe fluid retention, nerve pain, weakness, diarrhea, nausea, vomiting, breathing difficulties, joint pain ... and death. And Taxotere’s life-prolonging promise is minimal, at best.
Unlike Taxotere, which is essentially a poison targeted to kill cancer cells before they interfere with regular cells, Provenge attempts to re-engage the body's own immune system, encouraging it to more readily recognize cancer and defend against it … naturally. And its possible side-effects include mild fever and chills, lasting only a few days (end of list).
Shortly after I became interested in Dendreon the FDA was advised by its own appointed panel of seventeen experts (oncologists, urologists, and immunologists) that Provenge is unequivocally safe. The vote was unanimous, 17-0. The panel also agreed, 13 to 4, that that there was ‘substantial evidence’ of the drug’s effectiveness, as per FDA parameters.
Three of the panel members who voted on Provenge’s effectiveness had admitted conflicts of interest (which would most likely have rendered them unable to serve on the panel, had the newer FDA rules on conflicts been in effect then). Had they been barred from the decision-making process, the effectiveness vote would then have been a whopping 13 to 1.
Approximately 30,000 men die in the U.S. every year from late stage Androgen Independent Prostate Cancer (AIPC). Once a man has reached this stage, his survival expectancy is approximately nineteen months. And one analysis, performed by the principal investigator of Taxotere, suggested that the combined use of Provenge with Taxotere increased survival by an incredible fourteen additional months, as opposed to survival rates in patients receiving Taxotere alone.
Despite the fact that the FDA follows the recommendations of its advisory panels ninety-eight percent of the time, in May of 2007, the FDA declined to approve Provenge, demanding more evidence of its effectiveness, and requiring further study.
There has been countless speculation regarding the reason the FDA did not follow its historical record of approving such a safe, effective and revolutionary ‘drug’. Those explanations in which I place credence fall into two categories: (1) the power of Wall Street big money, and (2) the power of the chemotherapy cabal.
(1) There is an historical enormous ‘short interest’ in the stock of Dendreon – big money investors who bet big that this company would fail. At any given time, the short interest in Dendreon’s stock (DNDN) has been as high as 35%. Much ‘naked shorting’ has occurred in this stock – i.e., the selling of ‘phantom shares’, presumably (at least in this case) to artificially drive down the price of the stock in order to (a) prevent those who bet against the company from losing their shirts, or (b) destroy the company itself.
The problems for fledgling biotech companies are many. They are not only required to conduct financially prohibitive research, but, perhaps even more prohibitive, they must battle Wall Street corruption. Hedge funds, naked shorting, and stock analysts with an axe to grind represent a cancer of their own kind.
(2) The deeply entrenched chemotherapy dynasty is a multi-billion dollar business, and the big pharmaceutical giants are not about to let go of that cash cow without a fight. They have powerful connections in high places.
This past Tuesday, Dendreon announced the results of the extended trial that the FDA demanded when approval was refused two years ago. To simplify those results: the numbers released were astounding – considered by most in the medical community to be a ‘home run’. Urologists and oncologists – some of whom had been sitting on the fence – are now clamoring to be able to use this new tool, and the medical world is describing the expected approval of Provenge as the dawn of a new era in the treatment of prostate cancer. Skeptics have been won over. Numbers don’t lie.
The trial results were announced on Tuesday afternoon. Shortly before those results were made public, a criminal manipulation of DNDN stock occurred on Wall Street. Many are calling it ‘The unexplained DNDN Crash’. Take a look at the chart for DNDN stock that day:
Trading in DNDN was halted by the SEC at 1:27 PM. Just minutes before, the stock fell from $24.60/share to $7.50/share in just over one minute’s time. There were over 4,000 trades placed during that one minute, with about 3 million shares -- about half of an entire day's volume ‘changing hands’ in one minute's time. Keep in mind: this all occurred shortly before blockbuster results of Provenge’s clinical trial were announced.
This is nothing short of Wall Street terrorism.
Many honest retail investors lost a great deal of money in this criminal bear attack. And many back stage Wall Street big-money people covered potential losses.
The ‘regulators’ at NASDAQ ‘examined’ -- for all of then minutes -- the precipitous, unexplained drop in share price and allowed the trades to stand.
I was heartsick when I witnessed the latest blatant attempt to ambush this company and its products – but I, personally, have little to lose but money. Men (husbands, fathers, brothers, sons) worldwide are enduring indescribable physical and mental agony, and are losing their lives to a horrific disease, at the rate of more than eighty of them every day, while this company and its life-enriching product are being played with, as if they were nothing more than plastic disks in a game of tiddly winks.
Is there anything more vile and repugnant in this world than injustice? And is there anything more evil than injustice brought about by human greed and corruption … and resulting in agony and death for thousands upon thousands of innocent others?
I remember, decades ago, a time when the American people possessed an innate assurance that, no matter what kind of tragedy occurred or what brand of unfairness we had to weather, there was always the promise that someone in power was out there to at least listen to our grievances – and there was a justice system that would, more than likely, see to it that those grievances would be addressed, resulting in ultimate ‘fairness’.
That was a time in which those in power – in the three branches of government, and in the higher echelons of the free market system – had the good of the country, and its citizens, at the top of their list of priorities.
Such is no longer the case. Justice, and the concept of ‘fairness’, have been co-opted by self absorbed men, posing as ‘leaders’, with an unquenchable thirst for wealth and power.
... which is the reason those of us who believe in good science – and, more importantly, good science that appears to have the capability of improving the lot of humankind by alleviating suffering – are having difficulty believing that that science will be allowed to achieve its promise in this unsettled, uncertain era.
Two years ago we witnessed the triumph of greed and corruption over scientific innovation and success. And, in the two years that have elapsed since that infamous ‘triumph’, we have mourned the deaths, and lamented the torment, of nearly sixty thousand men who might have benefited from the science that remains in a greed-and-corruption-authored log jam.
Over the past two years, enemies of Provenge have continued to make end runs around the approval process by lighting brush fires outside of the normal channels -- by using the print medium to stir up controversy. Financial ‘analysts’ and ‘journalists’ continue to quote incorrect facts and make bogus future projections in an effort to stymie approval as well. Conflicts of interest on the part of medical professionals, and huge potential dollar losses on the part of hedge funds and short sellers, appear to represent the stuff of which an alliance continues to me made. And that malevolent alliance appears bound and determined to see to it that reasonable doubt is manufactured as to the credibility of the completed trials, and the future promise, of Provenge.
Now we sit here … having read the amazing numbers that were revealed on Tuesday … numbers that offer continuing proof of this revolutionary technology and its promise in the battle against one of history’s most dreaded diseases.
Dendreon has announced that it intends to file its new BLA (Biologic License Application) for Provenge to the FDA in the last quarter of the year. They intend to be meticulous -- to cross every T and dot every I, so that nothing can be found amiss in their data or its presentation.
Between now and then there will no doubt be additional sniper fire, and outright ambushes, by those, both on Wall Street, and in the chemotheraphy cabal, who intend to continue to place roadblocks in front of a revolutionary medical breakthrough.
We need to pray that those who know the truth, and whose motives are to alleviate human suffering, are armed to the teeth with the facts – and that the new FDA decision-makers see it as their duty to use those facts to the benefit of the people whose very lives depend on their integrity.
~ joanie
Below is an essay I posted on my political weblog this morning regarding the history of Provenge. It is surely too ‘elementary’ for many here on this forum, but I wanted it to be easily understood by readers who are not familiar with Dendreon.
I am nowhere near as knowledgeable as many on this board regarding the scientific facts and figures involved in Provenge’s development and potential. For those who have the time and inclination to read it, I would appreciate any additions, corrections, constructive criticisms. TIA.
Anatomy of an Ambush
About five years ago I began following a small biotech company called Dendreon. I did a great deal of research on the company and began corresponding with people -- urologists, oncologists, researchers and clinicians -- who knew much more than I about the products in their pipeline, the process through which one must move in order to obtain FDA approval, and the conceivable potential of the vaccines that Dendreon was developing.
I became convinced that this company had several blockbuster products in its pipeline, so I purchased shares of the stock, continued to read experts’ opinions, and kept my ear open for developments, both positive and negative.
At the time, Dendreon’s most promising product, which appeared closest to FDA approval, was an anti-prostate cancer vaccine called Provenge. But following closely behind was a second vaccine -- this one for breast cancer -- called Neuvenge. Both vaccines concentrate on one antigen and a revolutionary cassette technology that has the potential to be a powerful tool in confronting many types of cancer. The development of the second vaccine had been sidelined for years due to financial concerns. A small fledgling biotech company is not awash in cash.
The current most common treatment for advanced stage prostate cancer is a chemotherapy treatment called Taxotere, whose side-effects can be torturous – some of which include: low levels of white blood cells, anemia, hair loss, mouth sores, severe fluid retention, nerve pain, weakness, diarrhea, nausea, vomiting, breathing difficulties, joint pain ... and death. And Taxotere’s life-prolonging promise is minimal, at best.
Unlike Taxotere, which is essentially a poison targeted to kill cancer cells before they interfere with regular cells, Provenge attempts to re-engage the body's own immune system, encouraging it to more readily recognize cancer and defend against it … naturally. And its possible side-effects include mild fever and chills, lasting only a few days (end of list).
Shortly after I became interested in Dendreon the FDA was advised by its own appointed panel of seventeen experts (oncologists, urologists, and immunologists) that Provenge is unequivocally safe. The vote was unanimous, 17-0. The panel also agreed, 13 to 4, that that there was ‘substantial evidence’ of the drug’s effectiveness, as per FDA parameters.
Three of the panel members who voted on Provenge’s effectiveness had admitted conflicts of interest (which would most likely have rendered them unable to serve on the panel, had the newer FDA rules on conflicts been in effect then). Had they been barred from the decision-making process, the effectiveness vote would then have been a whopping 13 to 1.
Approximately 30,000 men die in the U.S. every year from late stage Androgen Independent Prostate Cancer (AIPC). Once a man has reached this stage, his survival expectancy is approximately nineteen months. And one analysis, performed by the principal investigator of Taxotere, suggested that the combined use of Provenge with Taxotere increased survival by an incredible fourteen additional months, as opposed to survival rates in patients receiving Taxotere alone.
Despite the fact that the FDA follows the recommendations of its advisory panels ninety-eight percent of the time, in May of 2007, the FDA declined to approve Provenge, demanding more evidence of its effectiveness, and requiring further study.
There has been countless speculation regarding the reason the FDA did not follow its historical record of approving such a safe, effective and revolutionary ‘drug’. Those explanations in which I place credence fall into two categories: (1) the power of Wall Street big money, and (2) the power of the chemotherapy cabal.
(1) There is an historical enormous ‘short interest’ in the stock of Dendreon – big money investors who bet big that this company would fail. At any given time, the short interest in Dendreon’s stock (DNDN) has been as high as 35%. Much ‘naked shorting’ has occurred in this stock – i.e., the selling of ‘phantom shares’, presumably (at least in this case) to artificially drive down the price of the stock in order to (a) prevent those who bet against the company from losing their shirts, or (b) destroy the company itself.
The problems for fledgling biotech companies are many. They are not only required to conduct financially prohibitive research, but, perhaps even more prohibitive, they must battle Wall Street corruption. Hedge funds, naked shorting, and stock analysts with an axe to grind represent a cancer of their own kind.
(2) The deeply entrenched chemotherapy dynasty is a multi-billion dollar business, and the big pharmaceutical giants are not about to let go of that cash cow without a fight. They have powerful connections in high places.
This past Tuesday, Dendreon announced the results of the extended trial that the FDA demanded when approval was refused two years ago. To simplify those results: the numbers released were astounding – considered by most in the medical community to be a ‘home run’. Urologists and oncologists – some of whom had been sitting on the fence – are now clamoring to be able to use this new tool, and the medical world is describing the expected approval of Provenge as the dawn of a new era in the treatment of prostate cancer. Skeptics have been won over. Numbers don’t lie.
The trial results were announced on Tuesday afternoon. Shortly before those results were made public, a criminal manipulation of DNDN stock occurred on Wall Street. Many are calling it ‘The unexplained DNDN Crash’. Take a look at the chart for DNDN stock that day:
Trading in DNDN was halted by the SEC at 1:27 PM. Just minutes before, the stock fell from $24.60/share to $7.50/share in just over one minute’s time. There were over 4,000 trades placed during that one minute, with about 3 million shares -- about half of an entire day's volume ‘changing hands’ in one minute's time. Keep in mind: this all occurred shortly before blockbuster results of Provenge’s clinical trial were announced.
This is nothing short of Wall Street terrorism.
Many honest retail investors lost a great deal of money in this criminal bear attack. And many back stage Wall Street big-money people covered potential losses.
The ‘regulators’ at NASDAQ ‘examined’ -- for all of then minutes -- the precipitous, unexplained drop in share price and allowed the trades to stand.
I was heartsick when I witnessed the latest blatant attempt to ambush this company and its products – but I, personally, have little to lose but money. Men (husbands, fathers, brothers, sons) worldwide are enduring indescribable physical and mental agony, and are losing their lives to a horrific disease, at the rate of more than eighty of them every day, while this company and its life-enriching product are being played with, as if they were nothing more than plastic disks in a game of tiddly winks.
Is there anything more vile and repugnant in this world than injustice? And is there anything more evil than injustice brought about by human greed and corruption … and resulting in agony and death for thousands upon thousands of innocent others?
I remember, decades ago, a time when the American people possessed an innate assurance that, no matter what kind of tragedy occurred or what brand of unfairness we had to weather, there was always the promise that someone in power was out there to at least listen to our grievances – and there was a justice system that would, more than likely, see to it that those grievances would be addressed, resulting in ultimate ‘fairness’.
That was a time in which those in power – in the three branches of government, and in the higher echelons of the free market system – had the good of the country, and its citizens, at the top of their list of priorities.
Such is no longer the case. Justice, and the concept of ‘fairness’, have been co-opted by self absorbed men, posing as ‘leaders’, with an unquenchable thirst for wealth and power.
... which is the reason those of us who believe in good science – and, more importantly, good science that appears to have the capability of improving the lot of humankind by alleviating suffering – are having difficulty believing that that science will be allowed to achieve its promise in this unsettled, uncertain era.
Two years ago we witnessed the triumph of greed and corruption over scientific innovation and success. And, in the two years that have elapsed since that infamous ‘triumph’, we have mourned the deaths, and lamented the torment, of nearly sixty thousand men who might have benefited from the science that remains in a greed-and-corruption-authored log jam.
Over the past two years, enemies of Provenge have continued to make end runs around the approval process by lighting brush fires outside of the normal channels -- by using the print medium to stir up controversy. Financial ‘analysts’ and ‘journalists’ continue to quote incorrect facts and make bogus future projections in an effort to stymie approval as well. Conflicts of interest on the part of medical professionals, and huge potential dollar losses on the part of hedge funds and short sellers, appear to represent the stuff of which an alliance continues to me made. And that malevolent alliance appears bound and determined to see to it that reasonable doubt is manufactured as to the credibility of the completed trials, and the future promise, of Provenge.
Now we sit here … having read the amazing numbers that were revealed on Tuesday … numbers that offer continuing proof of this revolutionary technology and its promise in the battle against one of history’s most dreaded diseases.
Dendreon has announced that it intends to file its new BLA (Biologic License Application) for Provenge to the FDA in the last quarter of the year. They intend to be meticulous -- to cross every T and dot every I, so that nothing can be found amiss in their data or its presentation.
Between now and then there will no doubt be additional sniper fire, and outright ambushes, by those, both on Wall Street, and in the chemotheraphy cabal, who intend to continue to place roadblocks in front of a revolutionary medical breakthrough.
We need to pray that those who know the truth, and whose motives are to alleviate human suffering, are armed to the teeth with the facts – and that the new FDA decision-makers see it as their duty to use those facts to the benefit of the people whose very lives depend on their integrity.
~ joanie
1/5 2009 20:49 fistandanti 09752 Der er efterhånden opbygget så meget forventning til godkendelse af Provenge at FDA ligger under et kæmpemæssigt pres. Mange følelser er også involveret.
FDAs biostatistikere forholder sig selvfølgelig fuldstændig objektivt når data skal analyseres.
Konklusionen fra biostatistikernes analyse af PROVENGE fase 3 tilbage i 2007, som viser at den manglende tiltro til Provenges effekt, trods alt havde noget på sig.
http://www.stockpickr.com/problog/952/
Bla. lidt kritik af IMPACT
Pris for beh. m. Taxtotere : 25,000 dollars.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aMk1RlczYgQU&refer=healthcare
FDAs biostatistikere forholder sig selvfølgelig fuldstændig objektivt når data skal analyseres.
Konklusionen fra biostatistikernes analyse af PROVENGE fase 3 tilbage i 2007, som viser at den manglende tiltro til Provenges effekt, trods alt havde noget på sig.
http://www.stockpickr.com/problog/952/
Bla. lidt kritik af IMPACT
Pris for beh. m. Taxtotere : 25,000 dollars.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aMk1RlczYgQU&refer=healthcare
2/5 2009 01:11 alpehue 09762 Ja - og når insiderne begynder, at sælge, så er det vel tide, at tage gevinster ?
http://www.marketwatch.com/video/asset/4A64D682-ADD0-4436-8B72-6B6DA0BF9D41
http://www.marketwatch.com/video/asset/4A64D682-ADD0-4436-8B72-6B6DA0BF9D41
2/5 2009 01:19 Hya 09764 insidersalg? har der været flere end de der var meddelt planlagt gennem lang tid - fordi man går på pension?
jeg har ihvertfald ikke modtaget flere sec meddelser om nye insidersalg
men naturligvis bruges den info - til at nedgøre kursen - du skal huske på at der fortsat er over 23% brændte shorts - og optioner der udløber den 9 maj
så alle kneb gælder
samtidig med at firmaet forsøger at hindre"fjendtlig overtagelse af firmaer" med nogen forslag til generalforsamlingen i juni
DNDN aktien har altid været god for manipulationer og kurssving
jeg holder min long position
og ser frem til den kommende tids udvikling omkring provenge.
Hya
jeg har ihvertfald ikke modtaget flere sec meddelser om nye insidersalg
men naturligvis bruges den info - til at nedgøre kursen - du skal huske på at der fortsat er over 23% brændte shorts - og optioner der udløber den 9 maj
så alle kneb gælder
samtidig med at firmaet forsøger at hindre"fjendtlig overtagelse af firmaer" med nogen forslag til generalforsamlingen i juni
DNDN aktien har altid været god for manipulationer og kurssving
jeg holder min long position
og ser frem til den kommende tids udvikling omkring provenge.
Hya
2/5 2009 01:23 CharlesPonzi 09765 Sælg, de kan købes billigere om mindre end 10 dage.
Senest på fredag kommer braget ned, og lige nu prøver FED på at begrænse skaderne.
Senest på fredag kommer braget ned, og lige nu prøver FED på at begrænse skaderne.
2/5 2009 15:50 Hya 09804 Cancer Patients Deserve Faster Access to Life-Saving Drugs
Companies should be able to promote all uses of their drugs that are reliably shown to be effective.
By RICHARD A. EPSTEIN
As President Barack Obama's new Food and Drug Administration team of Margaret Hamburg and Joshua Sharfstein take the reins, they must decide what to do with off-label uses of FDA-approved drugs. Right now these drugs provide immense life-saving opportunities for many sick patients, particularly those threatened by cancer. The FDA and Congress should protect physicians' and patients' right to off-label uses -- and for the first time allow drug makers to promote off-label uses that prove beneficial.
At present, no drug can reach the market without FDA approval. That approval is explicitly limited to the specific indications that have been subjected to exhaustive clinical tests, which usually take around seven years to complete, typically at the cost of hundreds of millions of dollars. Yet once a drug reaches the market, the FDA has no statutory power to "limit or interfere with the authority of a health-care practitioner to prescribe" how physicians use that drug to treat their patients.
Thus drugs licensed by FDA for one purpose are deployed for a second "off label" use on which clinical trials have not been run or, if run, not completed. These uses are neither fragmentary nor episodic. In 2008, Mark Ratner and Trisha Gura reported in Nature that estimates for off-label use of cancer drugs run from 50% to 70% of total usage, and perhaps higher.
There is ample reason for this extensive off-label use. Cancer patients are often in desperate straits. And when existing treatments fail, patients and physicians alike can rationally conclude that they lose nothing by rolling the dice.
Clinical trials sometimes give way to educated guesses that a drug approved for one kind of tumor might treat a second. In many instances the result is failure. But when early results from clinical trials suggest favorable results on which the FDA is unwilling to act, off-label use begins in earnest.
The drug Avastin, for example, already had FDA approval for treating lung and colorectal cancer when early clinical trials suggested in 2005 that adding Avastin to breast cancer treatments retarded tumor spread. Oncologists pounced on these results long before Avastatin ultimately received FDA approval for breast cancer in 2008. It was a case where bottom-up markets did an end-run around top-down regulation.
Any reliable information about what drugs work has the potential to save lives -- but the FDA's slow and ponderous system can't respond in real time to new data. Yet the gap between the FDA and the ordinary physician is being filled by the National Comprehensive Cancer Network (NCCN), a nonprofit alliance of 21 leading cancer centers, which gathers and evaluates information on off-label uses, much of which it publishes in its own journal.
This information is regarded as sufficiently reliable that -- after some initial hesitation -- Medicare now reimburses physicians and hospitals for off-label uses at much considerable cost to its own budgets. Moreover, the NCCN guidelines are commonly accepted in practice as setting the standard of care in medical malpractice cases.
The FDA is a bystander to this process. But it makes sure to raise its administrative sword against any drug company that dares promote the off-label uses of its products. For example, Pfizer was fined $430 million for the off-label promotion of Neurontin for migraine headaches. Serono Labs ponied up over $700 million to settle charges of the illegal promotion of its synthetic growth hormone, Serostim, used to combat AIDS-related wasting.
This absurd situation calls into question the entire FDA approval system for cancer drugs.
As matters now stand, no off-label use is possible for any drug that has not been certified for some particular on-label use. That necessarily reduces the number of drugs available on the market for off-label experimentation.
Sometimes the results are quite perverse. A promising drug fails its clinical tests, for example, because the data collection at a particular site may not have been properly monitored. Physicians following the trial could easily conclude that some related drug currently on the market might be suitable for the same purpose. So that drug is used off-label, while the newer one, which could easily be superior, remains on the shelf, perhaps forever. Such may be the fate of Pharmacyclic's Xcytrin, which was tested for treating the brain metastases of lung cancer in a $300 million-plus clinical trial that went awry on data collection at one site. The FDA has demanded new clinical trials that may be too expensive to complete. So physicians resort to the off-label use of Temodar (temozolamide), for which the evidence of clinical efficacy is much weaker.
Remember, recruiting subjects for the ever greater number of clinical trials required for drug approval is no easy task. The number of patients required per trial increased from around 1,600 in the late 1970s to around 4,200 in the mid-1990s and more since then. Patients are not available in the U.S. in endless numbers, and many will rightly stay out of clinical trials for untested drugs if they think that some off-label use of an existing drug is more promising.
In order to speed up its approval process for cancer drugs, the FDA introduced its Critical Path initiative in 2004. But its expedited processes have become bogged down, as the FDA has turned cautious after the negative publicity from the withdrawals of drugs like Rezulin and Vioxx. This threatens further contraction in the universe of new cancer drugs.
So what should be done? No one thinks that unapproved cancer drugs should be freely available to patients in the over-the-counter market. Yet once a drug passes Phase I clinical trials -- which test for high toxicity -- why not make it available for general distribution through the NCCN, which has far superior access to specialized medical expertise than the FDA? The blunt fact is that no matter how able FDA scientists and physicians are, none of them have the years of experience dealing with particular tumors and particular drugs that specialist scientists and physicians can bring to this project.
This may sound radical. But when lives are at stake, we should consider drastic measures.
Mr. Epstein is a professor of law at the University of Chicago and a senior fellow at Stanford University's Hoover Institution.
Companies should be able to promote all uses of their drugs that are reliably shown to be effective.
By RICHARD A. EPSTEIN
As President Barack Obama's new Food and Drug Administration team of Margaret Hamburg and Joshua Sharfstein take the reins, they must decide what to do with off-label uses of FDA-approved drugs. Right now these drugs provide immense life-saving opportunities for many sick patients, particularly those threatened by cancer. The FDA and Congress should protect physicians' and patients' right to off-label uses -- and for the first time allow drug makers to promote off-label uses that prove beneficial.
At present, no drug can reach the market without FDA approval. That approval is explicitly limited to the specific indications that have been subjected to exhaustive clinical tests, which usually take around seven years to complete, typically at the cost of hundreds of millions of dollars. Yet once a drug reaches the market, the FDA has no statutory power to "limit or interfere with the authority of a health-care practitioner to prescribe" how physicians use that drug to treat their patients.
Thus drugs licensed by FDA for one purpose are deployed for a second "off label" use on which clinical trials have not been run or, if run, not completed. These uses are neither fragmentary nor episodic. In 2008, Mark Ratner and Trisha Gura reported in Nature that estimates for off-label use of cancer drugs run from 50% to 70% of total usage, and perhaps higher.
There is ample reason for this extensive off-label use. Cancer patients are often in desperate straits. And when existing treatments fail, patients and physicians alike can rationally conclude that they lose nothing by rolling the dice.
Clinical trials sometimes give way to educated guesses that a drug approved for one kind of tumor might treat a second. In many instances the result is failure. But when early results from clinical trials suggest favorable results on which the FDA is unwilling to act, off-label use begins in earnest.
The drug Avastin, for example, already had FDA approval for treating lung and colorectal cancer when early clinical trials suggested in 2005 that adding Avastin to breast cancer treatments retarded tumor spread. Oncologists pounced on these results long before Avastatin ultimately received FDA approval for breast cancer in 2008. It was a case where bottom-up markets did an end-run around top-down regulation.
Any reliable information about what drugs work has the potential to save lives -- but the FDA's slow and ponderous system can't respond in real time to new data. Yet the gap between the FDA and the ordinary physician is being filled by the National Comprehensive Cancer Network (NCCN), a nonprofit alliance of 21 leading cancer centers, which gathers and evaluates information on off-label uses, much of which it publishes in its own journal.
This information is regarded as sufficiently reliable that -- after some initial hesitation -- Medicare now reimburses physicians and hospitals for off-label uses at much considerable cost to its own budgets. Moreover, the NCCN guidelines are commonly accepted in practice as setting the standard of care in medical malpractice cases.
The FDA is a bystander to this process. But it makes sure to raise its administrative sword against any drug company that dares promote the off-label uses of its products. For example, Pfizer was fined $430 million for the off-label promotion of Neurontin for migraine headaches. Serono Labs ponied up over $700 million to settle charges of the illegal promotion of its synthetic growth hormone, Serostim, used to combat AIDS-related wasting.
This absurd situation calls into question the entire FDA approval system for cancer drugs.
As matters now stand, no off-label use is possible for any drug that has not been certified for some particular on-label use. That necessarily reduces the number of drugs available on the market for off-label experimentation.
Sometimes the results are quite perverse. A promising drug fails its clinical tests, for example, because the data collection at a particular site may not have been properly monitored. Physicians following the trial could easily conclude that some related drug currently on the market might be suitable for the same purpose. So that drug is used off-label, while the newer one, which could easily be superior, remains on the shelf, perhaps forever. Such may be the fate of Pharmacyclic's Xcytrin, which was tested for treating the brain metastases of lung cancer in a $300 million-plus clinical trial that went awry on data collection at one site. The FDA has demanded new clinical trials that may be too expensive to complete. So physicians resort to the off-label use of Temodar (temozolamide), for which the evidence of clinical efficacy is much weaker.
Remember, recruiting subjects for the ever greater number of clinical trials required for drug approval is no easy task. The number of patients required per trial increased from around 1,600 in the late 1970s to around 4,200 in the mid-1990s and more since then. Patients are not available in the U.S. in endless numbers, and many will rightly stay out of clinical trials for untested drugs if they think that some off-label use of an existing drug is more promising.
In order to speed up its approval process for cancer drugs, the FDA introduced its Critical Path initiative in 2004. But its expedited processes have become bogged down, as the FDA has turned cautious after the negative publicity from the withdrawals of drugs like Rezulin and Vioxx. This threatens further contraction in the universe of new cancer drugs.
So what should be done? No one thinks that unapproved cancer drugs should be freely available to patients in the over-the-counter market. Yet once a drug passes Phase I clinical trials -- which test for high toxicity -- why not make it available for general distribution through the NCCN, which has far superior access to specialized medical expertise than the FDA? The blunt fact is that no matter how able FDA scientists and physicians are, none of them have the years of experience dealing with particular tumors and particular drugs that specialist scientists and physicians can bring to this project.
This may sound radical. But when lives are at stake, we should consider drastic measures.
Mr. Epstein is a professor of law at the University of Chicago and a senior fellow at Stanford University's Hoover Institution.
2/5 2009 19:48 alpehue 09814 Hej Hya
Af mit link fremgik vist, at man fandt det rimeligt, at der var lidt insidersalg ekstra, og at det var dem vel undt !
Men mådke det betyder, at kursen er vel høj.
Jeg vil også gerne have en long position, men helst lidt billigere. :)
Af mit link fremgik vist, at man fandt det rimeligt, at der var lidt insidersalg ekstra, og at det var dem vel undt !
Men mådke det betyder, at kursen er vel høj.
Jeg vil også gerne have en long position, men helst lidt billigere. :)
2/5 2009 20:07 cyber 09818 Man må vist sige, at insidere i DNDN er gået til biddet....
http://www.secform4.com/insider-trading/1107332.htm
http://www.secform4.com/insider-trading/1107332.htm
2/5 2009 20:24 CHjort 09821 President & CEO Gold Mitchell lever da til fulde op til sit navn Gold 
Shares Traded: 600.000 Sold. (samme dag Exercise 542.928 Exercise)
Avarage Price: 24.92 USD ( Exercise 6.52 USD)
Total Amount: 14.952.360 USD (Exercise 3.543.959 USD)
Tja, det må da siges at være et godt Daytrade
Shares Traded: 600.000 Sold. (samme dag Exercise 542.928 Exercise)
Avarage Price: 24.92 USD ( Exercise 6.52 USD)
Total Amount: 14.952.360 USD (Exercise 3.543.959 USD)
Tja, det må da siges at være et godt Daytrade
2/5 2009 21:50 Hya 09824 der har været flere salg
gold har igen solgt under 1/3 del af sin "aktie optionsløn"
og det har andre også
samtidig med at een meddeler planlagt salg på 1/36 pr gang fremover
men det har jeg nu ik ondt af
de ejer fortsat mange aktier- og var det mig selv, ville jeg også realisere lidt af gevinsten nu
da de jo ikke har haft mange muligheder tidligere for at score gevinsterne.
Hya
gold har igen solgt under 1/3 del af sin "aktie optionsløn"
og det har andre også
samtidig med at een meddeler planlagt salg på 1/36 pr gang fremover
men det har jeg nu ik ondt af
de ejer fortsat mange aktier- og var det mig selv, ville jeg også realisere lidt af gevinsten nu
da de jo ikke har haft mange muligheder tidligere for at score gevinsterne.
Hya
3/5 2009 18:21 alpehue 09868 Hya - "brændt barn skyder ilde"
>>du skal huske på at der fortsat er over 23% brændte shorts - og optioner der udløber den 9 maj, så alle kneb gælder<<
Betyder det, at der indtil 9. maj må forventes, at de skal købe ind ?
Og at man efter 9. kan forvente kursfald ?
Mvh
alpehue
>>du skal huske på at der fortsat er over 23% brændte shorts - og optioner der udløber den 9 maj, så alle kneb gælder<<
Betyder det, at der indtil 9. maj må forventes, at de skal købe ind ?
Og at man efter 9. kan forvente kursfald ?
Mvh
alpehue
3/5 2009 19:05 CHjort 09871 http://www.proinvestor.dk/index.php?p=debat&postid=8332
Tænk lidt på at en option er en kontrakt du indgår om et køb/salg. Hvis nu kursen for, her DNDN, ligger langt over dit væddemål kan du nu vælge 2 ting. Lad os antage, at du købte en kontrakt, som lød på retten til at købe DNDNtil kurs 8,-. Da du købte kontrakten var kursen måske 6,- og aktien var i optrend, du mente at kursen ville nå ca. 10,- d. 9.maj. (dette er dit "Bet"),du har derfor en ret til at købe DNDN til kurs 8,-. Men, du kan også vælge at sælge-indløse kontrakten til den kurs DNDN lander på d. 9/5. Udbyderen af alle disse kontrakter risikerer ikke, at kunne opfylde sin del af aftalen, for tænk nu hvis alle vil have aktier frem for cool cash?
1. du vil opfylde kontrakten og altså købe
Tænk lidt på at en option er en kontrakt du indgår om et køb/salg. Hvis nu kursen for, her DNDN, ligger langt over dit væddemål kan du nu vælge 2 ting. Lad os antage, at du købte en kontrakt, som lød på retten til at købe DNDNtil kurs 8,-. Da du købte kontrakten var kursen måske 6,- og aktien var i optrend, du mente at kursen ville nå ca. 10,- d. 9.maj. (dette er dit "Bet"),du har derfor en ret til at købe DNDN til kurs 8,-. Men, du kan også vælge at sælge-indløse kontrakten til den kurs DNDN lander på d. 9/5. Udbyderen af alle disse kontrakter risikerer ikke, at kunne opfylde sin del af aftalen, for tænk nu hvis alle vil have aktier frem for cool cash?
1. du vil opfylde kontrakten og altså købe
3/5 2009 19:30 karbold 09873 il det sige at de skal i market for at købe de aktier,og dette kan med føre en større stigning
2/5 2009 01:13 Hya 09763 http://stockcharts.com/h-sc/ui?s=dndn&p=D&b=5&g=0&id=p76980514984
efter en forrygende uge
Hya
efter en forrygende uge
Hya
