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Re: drbio45 post# 55734

Wednesday, 12/05/2007 11:32:59 PM

Wednesday, December 05, 2007 11:32:59 PM

Post# of 252505
I didn't view the panel, but in the past, if Pazdur wasn't supportive of the BLA, he would maneuver a way to let the biostatisticians dominate the discussion at the expense of the clinical discussion. Seeing as how there were two biostats people on the panel out of nine total members, I'm assuming that was the case this time as well (the DNDN panel had one biostat doc out of 17 members). I also think that sometimes consumer advocates pay more attention to toxicity than do oncologists, and Avastin's added toxicity may have been a major factor in the negative votes from the two consumer/patient advocates.

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