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walldiver

08/25/06 3:34 AM

#789 RE: ocyanblue #785

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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iwfal

08/27/06 12:48 PM

#802 RE: ocyanblue #785

Ocyan - Just an FYI on your thesis that the company can tell from the boosters how things are going. This is true to some degree but it is probably a pretty loose connection. A lot of info is lost in the integration.

A quick calc shows that for a given ratio of treated boosters given to placebo boosters given the conversion to HR has a standard deviation of 0.2.

So, the company can tell they are having some effect, but would be hard pressed to determine whether it was going to be stat sig unless the ratio was really a long long way from 2.0.