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Re: koman post# 34891

Tuesday, 05/19/2015 1:01:29 PM

Tuesday, May 19, 2015 1:01:29 PM

Post# of 732210
Nice find. I think that recent example with Bluebird Bio sounds exactly like what I was discussing that FDA guidance clause allowed for. The question is what goes on between the DMC, LP/NWBO and public communication if such an interim analysis success occurs allowing NWBO to proceed with AA while maintaining a blind. Is a halt still recommended? Is it bypassed? If by passed, is the public told? If the DMC recommends a halt, I think NWBO has to communicate it. So what is the mechanism beyond what you found? Regardless, nice find, I really appreciate that.

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