Wall Diver

Dendreon: Revisiting the Risk/Reward Scenario

While many on Wall Street still believe that the FDA won't approve Provenge on the current dataset, don't forget the recent survey of positive overall committee votes and subsequent FDA approvals. The positive panel votes were reaffirmed by the FDA approximately 97% of the time in that survey, although the survey didn't include ODAC, VRBAC, or CTGTAC, the latter being the committee that voted on Provenge. I would imagine that the percentage would stay close to 97% or even improve on that figure if these committees were included.

Also, don't forget that the CTGTAC chairman Dr. Mule was the one who asked for clarification on the efficacy question, and the head of CBER (the division which decides on whether or not to approve therapeutic and prophylactic vaccines) and the head of the Office of CTGT were the two people who changed the efficacy question to make it conform with the FDA's own guidelines for drug approvals.