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croumagnon

11/03/07 3:22 PM

#4993 RE: walldiver #4992

If I was in charge of DNDN, my decision to unblind 9902b early to look at TTP or not will depend on whether or not I feel that the survival interim look has a better chance at statistical significance than TTP...

For instance, if the interim look for survival has a 50% chance of having a p value less that 0.05 but TTP has a 80% chance of statistical significance, then I would probably elect to go early with TTP since my argument for approval is going to be based on supportiveness to 9901... Of course, if the interim has a decent chance at meeting the stringent interim survival p value, then I would wait till then before analyzing any data...