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Re: AVII77 post# 103245

Friday, 03/24/2017 1:24:18 PM

Friday, March 24, 2017 1:24:18 PM

Post# of 423561

Stopping for efficacy is not required. ...."The question a DSMB faces is not can we stop, but should we stop."



Yeahbutt.....the SPA has specific language that allows the trial to be stopped early for overwhelming efficacy.....the question under discussion is how does AMRN PR that they intend to complete R-IT if the requirements for an early halt are met, which presumably would require the DMC to inform AMRN they rec a halt - isn't it black and white, at least for PEs? If RRR > XX%, DMC must (should?) rec a halt, as it's part of the SPA. It's really not a question of can we or should we stop, it's how AMRN handles continuing the trial despite a rec to halt without unblinding the 80% results.

The Thought Police: To censor and protect. Craig Bruce

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