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
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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.
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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