9902A's 0.33 p value was my biggest worry heading into the briefing doc release/advisory panel meeting. But the negative aspects of both the briefing docs and the advisory panel focused on the TTP primary endpoint miss in 9901, and to a lesser extent, the TTP primary endpoint miss in 9902A. The letters that Pazdur ordered Scher and Hussain to write also focused primarily on the TTP miss, as did the Fleming letter. Even if 9902A was 0.10-0.15 for survival, I highly doubt Provenge would have been approved.
This is all a moot point anyway, as in many people's opinion (mine included), the CR letter was a political decision by CBER, who was inclined to approve, but caved in to CDER/OOD's threats during a crucial period for FDA/Congressional politics.
