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Re: debrry post# 690

Thursday, 08/17/2006 12:18:31 PM

Thursday, August 17, 2006 12:18:31 PM

Post# of 12660
The thinking is that since the trial enrollment was completed in June 2005, and the first interim look is triggered by a certain number of PSA threshold events, then the longer the trial drags on without the trigger occurring, the better it looks for Provenge.

Most patients should have "evented" 7 to 10 months after June 2005, based on trials conducted in the past. There has been speculation that the first interim look is triggered by 75% of the patients eventing, which for this trial is having a PSA score rising to 3.0 or higher. Historically, 75% of patients is about right, but it could just as easily be 50% or 2/3. DNDN has never released the # of events needed to trigger the first interim look.

Iwfal is the one who has looked into this more than me, so if I've quoted his figures wrong, I'm sure he will let us know.

Edit after reading Iwfal's post: one concern of ours is if whether or not the June 05 announcement of the trial completion of enrollment is also the date the last patient was randomized. Patients had to undergo Lupron treatment to get their PSA score down into the 0 to 1 range before being randomized to either Provenge or placebo.

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