Geoff,
"bladerunner, Do you really believe that Von E's biggest risk is a negative headline in NY Times inspired by Pazdur."
I don't know what you mean, Geoff, by "biggest risk," but it does pose a risk, IMO, yes. Von E. absolutely needs to present a "united front" to Congress as it considers how to "re-form" the FDA. Any sign of a "turf war" within the FDA, especially regarding oncology, would be a bad signal to send to Congress at this point.
As I have stated previously, I don't believe that the panel actually voted a "thumbs up" for approval. I think the panel--I don't think the panel knew exactly what they were voting on--voted a "thumbs down" to non-approval. This is not semantics; this is an absolutely crucial distinction to make. (I wouldn't doubt that the FDA is covertly re-polling the voting members of the panel to inquire whether they were voting for "approval" or "approvable." I bet Pazdur/Scher are pushing for them to do that. Look out for some panel member voting "yes" at the AC to now say that he/she meant to be voting for "approvable" not for "approval.")
"The FDA will make their own decision, based on the AC vote, the data, safety profile and the options currently available to men with prostate cancer. This, I believe, bodes well for Provenge."
I find that statement to be rather naive. With all due respect to the very, very, very erudite science-types posting here--and with a "hats off" to them for the lively and intelligent discussion here--the decision is no longer a scientific one; it is a purely political one.
Bladerunner
(I have never owned DNDN nor have I ever shorted it. And I have never advised anyone to go long or short on the stock. I have spent a good portion of my life studying bureaucracies and the way that people function within bureaucracies, whether governmental or corporate, socialist or capitalist. Hence, I must admit that I find this whole DNDN/Provenge/FDA thing really intriguing.)
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