Not to rain on the parade, just tossing out some info I found...
Forbes Article
Some highlights:
"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."
and
"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."
While this drug may reach market someday it could be a while and this may be a long term play. If trading you may want to but some May puts or write some covered calls in advance of the May 15th deadline. Some opinions I have read seems to believe that they will get an "approvable FDA letter", which will say that the drug will be approved if conditions are met. I have one example of a company that has tracked the DNDN story in a similiar way. Check out a 1 yr chart for POZN, notice the huge gap down in June of 06 when they were given an Approvable FDA Letter instead of full approval.
Good luck.
Forbes Article
Some highlights:
"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."
and
"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."
While this drug may reach market someday it could be a while and this may be a long term play. If trading you may want to but some May puts or write some covered calls in advance of the May 15th deadline. Some opinions I have read seems to believe that they will get an "approvable FDA letter", which will say that the drug will be approved if conditions are met. I have one example of a company that has tracked the DNDN story in a similiar way. Check out a 1 yr chart for POZN, notice the huge gap down in June of 06 when they were given an Approvable FDA Letter instead of full approval.
Good luck.
