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DewDiligence

03/07/12 3:55 PM

#138375 RE: Summer2762 #138373

Any hint that the futility boundary was binding?

Binding on whom? In general, a DSMB can stop a trial whenever it deems such action appropriate, regardless of any prior agreement with the trial sponsor.

IgnoranceIsBliss

03/07/12 4:49 PM

#138388 RE: Summer2762 #138373

Any hint that the futility boundary was binding?



We have no way of knowing that -- that would be an SPA provision, yes? I'd be surprised if it weren't, and the DMC would almost certainly reocmmend stop for futility if the hurdle were crossed -- and the DMC recommended a continue for START.

The pre-final alpha spend here is going to be tiny. Final alpha will be something like .02495 after the two tiny interim spends.

Regards,
TGW