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Re: walldiver post# 5085

Saturday, 11/24/2007 10:16:08 PM

Saturday, November 24, 2007 10:16:08 PM

Post# of 12660
RE: DSMB and the interim peek

I have always thought that the DSMB just used the prescribed goal for an early stop, and if not met keeps quite. Thus the DNDN would not know the P value is a near miss.

Even if somehow the company does have the data, I doubt the FDA would like an early stop when the SPA defined P value had not been met. The FDA in general does not like changes to trials in progress, especially if based on data from the trial.
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