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08/18/06 9:47 AM

#728 RE: alizumo #727

Alizumo - Thanks for the simulation effort.

But P-11's primary endpoint is not PSADT so you cannot rely on the P16 or D9905 published results as guides. P11 uses Time to PSA Recurrence defined as the time taken for PSA rising to >= 3ng/ml after nadir to <= 1ng/ml on a Lupron treatment. By the literature that I have seen, a good range to assume for the untreated median is somewhere between 7 to 11 months.

By r^2 and r^4, iwfal meant enrollment growing quadratically or by power of 4.