Replies to post #3712 on Dendreon Corp fka DNDNQ

[Gametheory101]

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.

[walldiver]

Correct me if I'm wrong, but I thought that you yourself mentioned that similar log rank results to the combined 9901/9902A dataset would have something like a 50-50 shot of hitting stat sig on the interim look if the reserved alpha was 0.01. I think that's assuming an HR of about 1.45, right? Assuming that the final unblinding occurs after Q1 2010, and considering (1) the larger trial size and (2) this would take place over three years after the 400th patient enrolled, then if Provenge is effective, it should easily beat p=0.03. So if that is the case then why not reserve more than what you normally would at the first interim?