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  1. [verwijderd] 17 april 2007 17:01
    quote:

    wishdom schreef:

    Analyst Comments Sponsored by:
    Brean Murray Notes Dendreon (DNDN) PROVENGE Panelist Voices Concerns to FDA
    04-16-2007 10:12:43 AM
    More Analyst Comments

    Brean Murray comments on Dendreon (Nasdaq: DNDN), saying a PROVENGE panelist voiced concerns to FDA. The firm said Dr. Howard Scher, who had voted against recommending PROVENGE for approval, recently published a letter to the FDA reiterating his vote and outlining his concerns. Scher said the FDA cannot approve PROVENGE based on data to date and the approval should be deferred.

    The firm said, Dr. Scher's letter points out the lack of data establishing clear efficacy of PROVENGE, poor trial design, and a concern over varying criteria required for different reviewing committees recommending approval to the FDA

    Groet.

    Dr. Scher is gewoon een ordinaire PAID BASHER.
    Hoeveel krijgt ie als de koers op $12, $13, $14, $15 of $16 staat? Door wie wordt ie dan betaald?
  2. [verwijderd] 17 april 2007 17:13
    quote:

    psycho-pharma schreef:

    [quote=wishdom]
    Analyst Comments Sponsored by:
    Brean Murray Notes Dendreon (DNDN) PROVENGE Panelist Voices Concerns to FDA
    04-16-2007 10:12:43 AM
    More Analyst Comments

    Brean Murray comments on Dendreon (Nasdaq: DNDN), saying a PROVENGE panelist voiced concerns to FDA. The firm said Dr. Howard Scher, who had voted against recommending PROVENGE for approval, recently published a letter to the FDA reiterating his vote and outlining his concerns. Scher said the FDA cannot approve PROVENGE based on data to date and the approval should be deferred.

    The firm said, Dr. Scher's letter points out the lack of data establishing clear efficacy of PROVENGE, poor trial design, and a concern over varying criteria required for different reviewing committees recommending approval to the FDA

    Groet.

    [/quote]

    Alles in zijn perspectief plaatsen graag Wish.

    Scher Commits Professional Suicide

    Two points Sher made in his letter should cost him his reputation and should bar him from future FDA advisory panels...
    Dr Sher, we know a lot of money is at stake. We know your bread is buttered elsewhere. We understand you have concerns. But you have sold your integrity down the river.

    First, and this is shocking, you argue in your letter that the non-statistically significant trend toward increased cerebral vascular events in the D9901 trial raises serious safety concerns and approval of Provenge should be delayed.

    Dr. Sher, the advisory panel voted 17-0 that Provenge is safe for the intended patient population. Dr. Sher, have you already forgotten that you were a member of the advisory panel and that you voted that Provenge is safe for the intended terminal patient population, after the cerebral vascular issue was discussed by the panel? Should we believe you were unqualified to sit on the panel and make judgements in a limited amount of time...or should we believe you are now lying about what you truly believe?

    If you were not qualified to render judgements on the panel, then why should we or the FDA believe you are qualified now? If you are instead lying, then why should we or the FDA believe anything you say.

    The second incredulous statement you made is that the frozen Provenge in the placebo arm may have actually decreased the life expectancy of the placebo arm, allowing the trial to show a survival benefit.

    Dr. Sher, the placebo arm lived longer than the Halabi nomogram predicted. Are you saying the Halabi nomogram is of no value in prostate cancer research? Or are you again being disingenuous?

    This letter, Dr. Sher, hopefully is a forgery and the crooks will be brought to justice. If it is indeed your letter, then one has to wonder if you are the "consultant" the hedge funds relied on to go so short the stock in total disregard of all proper risk management




    Tis niet de bedoeling om wat dan ook te proberen te verstieren,maar hoop alleen dat jullie vette winsten halen,en die Yanks op hun nummer zetten.
    Zo,n $10 van de koers af is toch een hoop pegels.

    Met vriendelijke groet.

    Sorry.
  3. [verwijderd] 17 april 2007 21:15
    Yahoo

    Re: Think about DNDN (Not rated) 47 minutes ago Fact vs. Fantasy has the answers
    Fact- Provenge did not meet some endpoints.
    Fact- The endpoints where old school chemo markers.
    Fact- Provenge extends survival.
    Fact -Provenge has a very benign adverse effect profile
    Fact- Provenge is an agent for a disease with unmet needs
    Fact- The FDA wants more agents for this disease state
    Fact- The FDA does not want to slow the progression of immunotherapy research
    Fact- The efficacy question was re-worded
    Fact -The efficacy question was re-worded by the FDA, not the committee
    Fact- The committee voted 13-4 in favor of efficacy
    Fact- The committee voted 17-0 in favor of safety
    Fact- There is compelling data to show Provenge/Taxotere is more effective than Taxotere alone
    Fact- The committee is aware of the Provenge/Taxotere data
    Fact- Scher allegedly has written a letter to the FDA imploring them to not approve
    Fact- Scher was and is on the old school ODAC committee
    Fact- The shorts and short analysts said the drug would not have a favorable review
    Fact- The committee gave a favorable review
    Fact- The price per share will go up and down until FDA decision
    Fact- There are still millions of shares short and possibly growing
    Fact- The shorts very seldom state any factual evidence as to why the FDA would not approve.
    Fact- The FDA overwhelmingly follows the recommendation of it’s advisory committees
    Fact- The FDA will rule on Provenge with-in 29 days
    Fact- The answer to the 18 billion dollar question will be answered

    Fantasy- FDA will not approve Provenge
    Fantasy-Analysts understand immunology, oncology, and the science behind each

    Are you investing in fact or fantasy??

    ---------

    Congratulations- you got a pat on the head from MoleculeMind.
    You want to talk facts, then lets talk about facts.
    When a clinical study is defined, control is established based on the endpoints. Now, Provenge didn't meet any (let's not mince words here) of its endpoints . You can go back and data snoop, and maybe decide that "survival was extended." The problem is, survival wasn't controlled for- in other words, what you have is more like a P2 result than a P3 result.
    I agree that the FDA wants to approve this drug. I also believe they can't justify it based on the data. That's why they appointed the panel. And, the panel didn't give them what they wanted- the panel gave them a watered down thumbs-up. We'll know if that's enough shortly.

    tinyurl.com/2tlks8

    P.
  4. [verwijderd] 19 april 2007 11:16

    Uit Motley Fool Rule Breakers:

    Volume 4, Issue 5, May 2007
    The Ultimate Growth Service
    rulebreakers.fool.com

    Biotech Beat: Dendreon

    If you've been following the biotech sector, you've surely heard about Dendreon's (Nasdaq: DNDN) cancer vaccine Provenge — and the stock's nearly fivefold increase in a single month. Dendreon's cancer vaccine platform uses novel technology to target metastatic prostate cancer, and it looks like bona fide Rule Breaker material. Dendreon has staked out a large lead over its competitors, giving it an important first-mover advantage.

    Despite this promise, until last month I felt that investing here was just too risky. I thought the Provenge data package was weak and likely to have higher than normal odds of receiving only an "approvable" letter from the FDA. The cancer vaccine landscape is littered with failures, including Antigenics (Nasdaq: AGEN), Biomira (Nasdaq: BIOM), and CancerVax, now part of Micromet (Nasdaq: MITI). There hasn't been a product approved yet that stimulates the immune system to attack cancer, and I didn't want to follow Dendreon down a dead end.
    A New Outlook

    I now believe Dendreon is poised to break new ground in cancer therapy. An FDA advisory panel unanimously backed the drug's safety and offered strong support on effectiveness. Clearly, I was wrong about Provenge's efficacy. I don't mind being wrong, though, when it means that a new drug will be available for patients with no other treatment options.

    The next major milestone for Dendreon will be the May 15 conclusion of a review period under the Prescription Drug User Fee Act, which is designed to keep the approval process moving quickly. At that point, the FDA will decide whether to approve Provenge. Though the FDA doesn't have to follow the opinions of its advisory panels, it almost always does. I expect that Provenge will be approved next month; it seems clear the agency wants this drug on the market.

    The FDA will probably want a commitment from Dendreon to complete an ongoing phase 3 clinical trial, and I think Provenge's status will be contingent upon positive survival data from that trial. If it fails, Provenge could very well be pulled from the market. That risk remains a few years away, and I wouldn't worry about that until the time comes.
    Opportunity to Profit

    A lot of risk has been removed from the company in the aftermath of the advisory committee's meeting. With FDA approval a near certainty, I think Dendreon is well worth considering right now. Taking a look at the numbers, I don't think we've missed the boat, despite the recent large increase in price.

    Commercially successful cancer drugs that are already on the market post sales of $500 million to $2 billion a year. Given that metastatic prostate cancer is a large market without satisfactory treatment options, I think Provenge could very reasonably hit $1 billion, which as far as I can tell is roughly the upper limit of its manufacturing capacity, though that could always be expanded to meet demand.

    Biotech drugs tend to be very profitable, leading to fat margins — 20% net margins are quite common in the industry. If Dendreon can successfully promote Provenge and capture industry-average margins, it could earn several hundred million dollars a year. At typical biotech multiples, Dendreon could still triple from its current levels. I think there's still room for this stock to run over the next two years, but bear in mind that down the road we'll need to factor in risk from the current phase 3 trial and competing products.
    The Competition: Cell Genesys

    Dendreon is the first mover in the prostate cancer vaccine space, and it has a lead of several years over the nearest legitimate competitor, Cell Genesys (Nasdaq: CEGE). It's been a good month for Cell Genesys, too, as its stock has nearly doubled. Part of that climb is certainly sharing in Dendreon's good fortune, as the FDA shows it's willing to give cancer vaccines a fair chance.

    Cell Genesys also released clinical data from a second phase 2 trial of its GVAX cancer vaccine in patients with metastatic prostate cancer. Both trials should be considered successful with impressive median survival results. But even with these positive outcomes, it would be folly to draw conclusions about GVAX's effectiveness. Neither trial had control arms in which a group of patients received a placebo. Historically, phase 2 data without a placebo control haven't been reliable predictors of success in phase 3.

    Cell Genesys is now conducting two phase 3 trials on GVAX. These are well-designed trials using an active chemotherapy drug, Taxotere, as the control group and in combination with GVAX. If the results are positive, the data would put GVAX on solid footing to compete with Provenge despite Dendreon's first-mover advantage. Results are likely two to three years away, though, giving Dendreon some time in the driver's seat.
  5. [verwijderd] 19 april 2007 13:02
    Philip Kantoff, a urological oncologist at Harvard Medical School and the Dana Farber Cancer Institute, is conducting a big clinical trial that should firmly establish whether and how much Provenge helps patients. He has consulted with Dendreon. For a long time, he was one of Provenge's doubters. "I thought the concept was too simplistic for belief," Kantoff says. "I didn't think it had a snowball's chance in hell of working."

    But the data showing the drug increases survival has made him cautiously optimistic. "I'm still skeptical, but I think there's something going on here," he says. His doubts rest mainly on the fact that results were small. "If this were a much larger study, to me this would be a slam dunk."

    Kantoff says that if the drug were approved, he would probably prescribe it. So far Provenge seems mostly to cause flu-like symptoms, but FDA reviewers note there may also be an increased risk of stroke. If the medicine is fairly safe and might be effective, why not offer it to patients?

    David Penson, a urologist at USC's Keck School of Medicine, has also gone from being a doubter to an investigator in a Provenge clinical trial and a consultant for Dendreon (he says he has received less than $10,000 in fees). "When they first released their data, they had to massage some data to show a clinical difference," he says. Dendreon's first study showed efficacy only in less-sick patients.

    Colleagues convinced Penson to give Provenge a try in clinical trials, and he was impressed. He remembers one patient, a doctor, who went from being wasted and fatigued from his metastatic prostate cancer to being able to play golf again. Patients don't care if a drug meets the original primary endpoint of Dendreon's study, an improvement in X-rays, says Penson. "All they care about is living longer."

    This is the argument at the heart of the case for Provenge. Neal Shore, medical director of the Carolina Research Center, says rejecting Provenge now would be "grossly unfair to the patients who have no other options but to enter clinical trials." Shore argues that "a lot of people will end up dying" before bigger clinical trials could show a benefit.

    But there are other issues at play. Once a drug is approved, other medicines can get on the market by proving they are better. If an ineffective drug slips through, that could open the door to other less effective medicines. Another worry is that the benefit of Provenge might be real but less robust than it appears. Because larger issues are at play, this is exactly the kind of situation in which the FDA might go against the decision of an advisory panel.
  6. [verwijderd] 19 april 2007 13:22
    Wanneer is hier duidelijkheid over?

    "The company is conducting a third study to test whether it improves survival in more than 400 patients. Experts said the results of that trial should have a heavy bearing on whether the FDA decides to approve Provenge".

    Interessant:

    "Several experts said the company had not established that Provenge works, but then voted to back it once FDA officials told them to base their votes only on the question of whether the evidence was "substantial."
  7. [verwijderd] 19 april 2007 15:20
    quote:

    ohmygod schreef:

    Wanneer is hier duidelijkheid over?

    "The company is conducting a third study to test whether it improves survival in more than 400 patients. Experts said the results of that trial should have a heavy bearing on whether the FDA decides to approve Provenge".

    2009/2010

    P.
  8. [verwijderd] 20 april 2007 00:47
    Did you notice on the CBER website at the FDA--(What's new)--they posted today a final version of new procedures for post marketing studies to which a company commits after receiving contingent approval?

    "There are generally two types of Postmarketing Commitments:

    a/ Required PMC - A study or studies required by FDA as a condition of marketing approval. Two examples are:
    accelerated approval clinical benefit studies, where the applicant is required to verify clinical benefit after approval (21 CFR 314.510 and 601.41); and
    deferred pediatric studies, where the applicant must assess the safety and efficacy of the product in all relevant pediatric subpopulations. >

    b/ Agreed Upon PMC - A study or studies that the FDA and applicant have agreed are necessary, generally to address a specific aspect of the safety or efficacy of the product. The agreement may be reached before or after approval of the application or supplement." ( www.fda.gov/cber/regsopp/8413.htm )

    Clearly, subsection (b) would seem to tailor for Provenge ! The writing is on the wall, shorts ...

    Hmmm...coincidence or dotting the "i's" and crossing the "t's" before Provenge is given approval contingent upon a commitment to finish and report results of 9902b?

    Time will tell, but my sense from the hearing was definitely that the sentiment of the panel--Dr. Mule in particular--and also of Dr. Witten--was to approve immediately so that dying patients could receive the treatment, but with a promise to complete the larger study and to try to enroll more minorities.

    At least today's posting sends a message that someone at the FDA has the idea of post marketing studies after approval on their front burner.

    Here's the link:
    www.fda.gov/cber/regsopp/8413.htm

    P.
  9. [verwijderd] 20 april 2007 09:51
    Nog even een mooie samenvatting op Yahoo.

    Here is why FDA should Appove Provenge (3 Ratings) 20-Apr-07 01:05 am So, I have to dig how much chance Provenge will get approved. Thanks for the links in this board, it takes me 3-4 hours of reading to conclude that FDA will approve. Here is why:

    1. the most arguement the shorts used is that it did not meet the endpoint. P-value is used to determine if pass the test. P < 0.05 is accepted by FDA. DNDN get the first trial with p=0.052, slightly miss the mark. When pooled with the second trial, they get p=0.011 overall. (after Cox regression correction, p=0.0006). It is highly reliabe test by FDA standard.

    2. Provenge changes patient's immune system. The benifit is more long term. It is even much better when combined with other drugs. It increases the survival time of 4.5 months when used Provenge alone. It add only 2.4 months if only treated by Taxoere. But it dramatically increased to 14 months, when combined Provenge and Taxoere. For a average 73 years old man, what else you could ask other than 14 month more life.

    3. DNDN was unlucky to choose TTP as an endpoint for the trial 8 years ago. If they choose survival as the endpoint of the trial, no one will have any doubt about FDA approve today. DNDN choose not to argue about TTP results, instead, they emphasize on survival. FDA agreed in writing that only survival can present evidence for approve. Provenge is statistically proven to be benifit for survival.

    4. Provenge is safe to use. Even Taxoere has 1-2% death rate directly result from side effect. What wrong to let old men take Provenge and live 4.5 to 14 months longer? For now, 50% of patient will die in three years after diagnosis.

    5. FDA never reject advisory commitee's recommendation. Will they reject for the first time for the drug that patients are crying for? I do not think so. There are 74 men die every 24 hour due to this illness. Even FDA direct is a patient of Prostate cancer.

    P.


  10. [verwijderd] 20 april 2007 10:12
    Ik kan je nog een tip geven,TELK wordt de volgende die omhoog knalt binnenkort.Het ziet er naar uit dat die gaat worden overgenomen(hebben zelfs 140 milj. dollar in kas bij 55 milj. aandelen)

  11. [verwijderd] 20 april 2007 19:05
    Pharmaceuticals
    The Danger In Dendreon
    Matthew Herper, 04.20.07, 12:00 PM ET








    Right now, Dendreon is the hottest stock in biotech. The tiny Seattle-based company could change the way tumors are treated with its medicine, Provenge, which teaches the immune system to battle prostate cancer.

    But right now, its stock is dangerous to buy, because its fate will be determined by unpredictable politics at the Food and Drug Administration, not the certainties of science. The whole Provenge story, however it turns out, provides an object lesson on the risks and big payoffs that can come from investing in biotech.

    Dendreon (nasdaq: DNDN - news - people ) scored a surprise win last month when a panel of FDA advisers recommended that Provenge be approved to treat men whose prostate cancer has spread to other parts of the body.

    The stock immediately tripled to almost $19 and kept rising all the way to $25. But now, shares have dropped back down to $16. Even on a normal day like Thursday, when nothing happened, Dendreon shares changed hands 30 million times, three times their average trading volume.

    The FDA has a legal deadline of May 15 to make a decision--although it is possible to break or extend it. But buying the stock in front of this deadline is probably highly risky. There is a reasonable chance the FDA will decide to go against the panel vote and ask for more data. And the downside to the stock if the FDA does delay approval by asking Dendreon for more data is probably much bigger than any potential gain.

    Why? For one thing, an approval might be priced in. Two years ago, Geoffrey Porges, an analyst at Sanford C. Bernstein, analyzed the likely performance of biotech stocks following FDA decisions.

    Some 70% of the time, Porges found, drugs were approved, and shares in their makers gradually rose. But when a drug failed, stocks cratered 40%. The net result is that betting that drugs are going to get approved is a good way to lose money. In contrast, if you shorted stocks before FDA decisions, you'd make money.

    Another problem is that the FDA is much less likely to follow the whims of its advisory committees than many investors seem to think. The agency does follow the advice of these committees most of the time, but there are plenty of reasons to believe Dendreon might be an exception.

    Dendreon's application to the FDA contains two late-stage studies with a combined total of 225 patients. That's tiny; many drugs are tested in studies of thousands of patients. Both studies missed their main goal, but the more recent one--a three-year, 124-patient study--shows that patients on the drug lived, on average, an extra four months.

    But statisticians, and the FDA, tend to toss out studies that don't make their main goal. To cancer patients, this can sound insensitive. But there's a real reason for it. When a study gives a result that scientists didn't predict ahead of time, it's simply more likely that the result happened by chance.

    The panel did weigh those risks, and it still recommended Provenge by a 13-4 vote. One study shows that when an FDA panel recommends approval, the FDA will approve the drug 97% of the time. Both a concerned investor and Dendreon's outside public relations firm point to this research, conducted by the National Research Center for Women & Families.

    That statistic is misleading, though, because the study counts approvals that happened months or years after the panel voted. Nobody expects the FDA to reject Provenge outright. Instead, the FDA would probably grant an "approvable letter," basically saying it will approve the drug if certain conditions are met. Dendreon is already conducting a 500-patient study that will give a much clearer answer as to whether Provenge works. If the drug is approved, it may make it difficult to conduct that placebo-controlled trial.

    Also, the NRCWF report basically argues that the FDA approves drugs too often. It is exactly the kind of criticism that could lead to the agency becoming more reticent. And it picked committees at random, missing the advisory committee for cancer drugs, where a lot of controversies happen. Also, it doesn't include two cases where the FDA did go against a committee.

    An advisory committee recommended that Merck's (nyse: MRK - news - people ) Vioxx be put back on the market; the FDA found a way to not bring it back without actually contradicting the committee's recommendation. And a committee recommended approval for Pargluva, a diabetes drug from Bristol-Myers Squibb (nyse: BMY - news - people ). After safety issues emerged, the FDA asked for a large study, basically killing the drug's chances.

    If the agency wants to ask Dendreon for more data, it certainly has some outs. The FDA changed the wording of a question during the panel, so instead of just saying Provenge should be approved, it said there was substantial evidence for its efficacy. Also, the panel that looked at Provenge was the one for cellular, tissue and gene therapies, not the panel that normally deals with cancer drugs.

    Richard Pazdur, head of the Office of Oncology Drug Products, has set a high bar for judging the effectiveness of cancer drugs. His office is completely removed from the one that convened the Provenge panel.

    Many of the panelists on the cellular, tissue and gene therapies panel were researchers, not doctors who treat patients. One of the "no" votes was Howard Scher, of the Memorial Sloan-Kettering Cancer Center, who has made a career of designing trials to test prostate cancer drugs. The Cancer Letter, an industry newsletter, obtained a confidential letter Scher sent to the FDA arguing that Provenge should not be approved. Memorial Sloan-Kettering says that Scher had nothing to do with making the letter public.

    In the letter, Scher voices four concerns: The recommendation to approve fell short of regulatory requirements; the statistics are "inadequate" to determine whether patients were helped; the data on safety are incomplete; and the advisory committee seemed to be using a different set of criteria compared to those for other cancer drugs.

    The panel vote does make an approval more likely. But the FDA can go against its panels, and it has in the past. There are plenty of reasons to delay approval until a big safety study emerges. And the pain of a rejection could be worse than the pleasure of approval. Until Dendreon gets a fax from the FDA, what happens next is anybody's guess.

  12. [verwijderd] 20 april 2007 19:30
    Goed artikel Wish, aanbevolen. Beter dan al die Yahoo-bagger die ter staving van het eigen gelijk wordt aangedragen op dit draadje.

    En,Thijs Vollenbroek, i.p.v. scherpe maar terechte kritiek weg te censureren: hebben jullie als IEX ook niet, net als de commerciele banken, een zekere "zorgtaak", in casu er voor te zorgen dat forumleden die hun schrijfsels meer gewicht in de schaal proberen te doen leggen door het pochen met aantallen aandelen, auto's, opleiding e.d., om zodoende de popupariteit van bepaalde gokaandelen te bevorderen, een beetje in de hand te houden?

    Of wordt dit afgedaan met het cliche van de "eigen verantwoordelijkheid" van de belegger, die zelf wel weet wat hij/zij doet?

    Groet Beur

  13. [verwijderd] 20 april 2007 20:19
    quote:

    beur schreef:

    Goed artikel Wish, aanbevolen. Beter dan al die Yahoo-bagger die ter staving van het eigen gelijk wordt aangedragen op dit draadje.

    En,Thijs Vollenbroek, i.p.v. scherpe maar terechte kritiek weg te censureren: hebben jullie als IEX ook niet, net als de commerciele banken, een zekere "zorgtaak", in casu er voor te zorgen dat forumleden die hun schrijfsels meer gewicht in de schaal proberen te doen leggen door het pochen met aantallen aandelen, auto's, opleiding e.d., om zodoende de popupariteit van bepaalde gokaandelen te bevorderen, een beetje in de hand te houden?

    Of wordt dit afgedaan met het cliche van de "eigen verantwoordelijkheid" van de belegger, die zelf wel weet wat hij/zij doet?

    Groet Beur

    O O O Beur, wat laat jij je in je kaart kijken!!
    Maar omdat aan jouw gemankeerde karma toch niets meer te doen is zou ik zeggen: Gewoon DOOOOOORGAAAAN!

    Psycho
    en aanbevolen, amice
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