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MI Dendream

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MI Dendream

Re: None

Tuesday, 10/31/2017 6:30:35 PM

Tuesday, October 31, 2017 6:30:35 PM

Post# of 700462
Suppose 110 PFS events triggered in June-July 2015 and the blinded DSM review saw approximately 55 cases in arm A and 55 cases in arm B. With 2:1 randomization, the randimization code could remain blind and yet DSM could make a determination of effect.

What might the DSM have done at that point? How would Linda react to a DSM recommendation? How would FDA respond?

Perhaps the last 2+ years provides an answer.
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