The Goal Posts for Dendreon at the FDA
The FDA appointed advisory committee on whether to recommend approval for Dendreon’s Provenge (sipuleucel-T) met in Washington, D. C. on March 29th. After voting unanimously to recommend Provenge as “reasonably safe,” the 17-member panel fell short of unanimity on whether the drug is effective. The first 4 votes were against. Following intervention by an FDA official, 13 members voted in favor. Accounts vary as to how and why the FDA official intervened during the vote.
(full story…)