From a strictly buraucratic/political perspective, Von E. has to come down on the conservative side and push for an "approvable" letter, a decision that can silence the critics both within and outside the FDA to a large extent. If he doesn't, then he risks reading a headline in the Washington Post/N.Y. Times (no doubt, inspired by Pazdur and Co.) that reads "Doctor on FDA panel claims FDA gives cancer patients false hope with approval of cancer vaccine." This is a risk that Von E. can't take right now with the fight in Congress ongoing.
bladerunner, Do you really believe that Von E's biggest risk is a negative headline in NY Times inspired by Pazdur.
How's this for a headline: Von E. fails to approve cancer vaccine that AC gave the thumbs up to 13-4, 17-0 re: safety.
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.
JMHO, as always.
Best regards,
Geoff
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