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Re: iwfal post# 3712

Sunday, 05/20/2007 2:24:01 PM

Sunday, May 20, 2007 2:24:01 PM

Post# of 12660
Three questions?

First, if memory serves correct Taxotere was compared to Prednisone which does not have a survival benefit. Hence, basically Taxotere was compared to a placebo. Is this close to being correct?

Second, doesn't the CD54 Upregulation data give Dendreon a way to estimate potential survival from any interim analysis minus non prostate cancer specific death, which went against Provenge anyway and should more positive this time? If so, potentially they could submit this data to the FDA after 9902B finishes enrollment as the alternative path, or, they could use this data as a guide in judging when to take an earlier interim look.

Finally, was the analysis by Dr. Petrylak comparing Patients who subsequently took Taxotere presented to the FDA? I do not remember if this data was submitted as part of the BLA. If not, then perhaps this could be the alternative data used. This assumes the FDA really just wants to enroll 9902B and doesn't want to wait for solid 9902B data. My WAG is political pressure will mount on the FDA to find an "alternative path" outside the SPA.
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