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Replies to #51502 on Biotech Values
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DewDiligence

08/24/07 10:39 PM

#51505 RE: walldiver #51502

>[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.
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p3analyze

08/24/07 10:55 PM

#51509 RE: walldiver #51502

"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?