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Gametheory101

05/12/07 2:31 AM

#3491 RE: iwfal #3478

Thought analysis of Provenge vs salvage frozen Provenge survival in 9901/2A had been done way back?[/]

According to Dr. Provost, the frozen Provenge had a similar CD54 Upregulation to the first infusion of fresh Provenge.

The second and third infusion of fresh Provenge used already previously infused blood and this created a much higher CD54 Upregulation.

This begs the question, just how beneficial might a fourth booster infusion be? If Dendreon is going to negotiate with the FDA to change the 9902B statistical plan to allow an earlier interim analysis, they should negotiate to allow a booster infusion for all Provenge patients still alive after 6 months.



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corpstrat

05/12/07 12:22 PM

#3499 RE: iwfal #3478

Analysis of Provenge vs frozen. I thought I'd seen discussed on the boards many months ago a sub-analysis of the 9901 (or combined) trial comparing survival of the treatment arm vs the placebo crossovers. Actually lengthy debates. Guess I must have imagined it if you (Clark), Ocyan and Walldiver don't recall it. Or were they speculative estimations without company-released data? I only insist of course because, if there are data, they would have some potential bearing on the chances of stat sig results at the interim and final analysis of 9902B.
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ocyanblue

05/12/07 2:10 PM

#3508 RE: iwfal #3478

I've discussed on the iVillage board about the possibility that frozen Provenge is inferior to fresh Provenge, primarily because the three doses are essentially three first doses, each with 2/3 of normal volume.