>[Pazdur] held up the Avastin sBLA to make a methodological point… He's playing with people's lives here, and he doesn't give a flying fu...squirrel.<
This is an sBLA—Avastin is already being used in breast cancer and the sales are significant, according to DNA. It’s doubtful that many (if any) “lives” have been sacrificed here.
"and an HR of 0.67 in interim overall survival aren't marginal results"
One of the slide in the linked ppt http://www.unich.it/mso.cinbo/eng/courses/2006/2006111617slides/1711am/13_Ciardiello.ppt showed a hazard ratio of 0.84 with p=0.12, was this after ealy stopping followed by taxol patients cross-over. Will this BLA update the long term OS data? Given what's shown here, at 50% information, the liklihood of final OS significant would be very low. Perhaps FDA saw this coming at time of first review?