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Re: ocyanblue post# 785

Friday, 08/25/2006 3:34:52 AM

Friday, August 25, 2006 3:34:52 AM

Post# of 12660
Ocyan, that's exactly the point we both have been making all along...almost all of the analysts who cover DNDN don't realize that the FDA dept reviewing the Provenge BLA will likely be CBER (Biotech Monthly being the most notable exception). And it was Ammass who first pointed this out and did all the digging behind the scenes in the Summer of 2005, actually phoning some of the top administrators at CBER and asking them which dept at the FDA would review any therapeutic vaccine BLAs.

As for Martino leaving ODAC, if it's really true then it's great news (almost too good to be true!), both for the potential path of the Provenge BLA, plus for all of the other cancer drugs coming up for review that deserve a competent chairperson presiding over the panel meeting. She is the Michael Brown of the outside advisory committees.
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