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Re: learningcurve2020 post# 76119

Saturday, 09/24/2016 7:36:22 PM

Saturday, September 24, 2016 7:36:22 PM

Post# of 721585
learningcurve2020,

FDA will almost never peek until there is no more plausible explanation. The DMC may have recommended a halt but until a median can be established for actual benefit, the company has a right to keep everything continuing to insure best benefit outcome. FDA can change things up, though, if they have reason to believe some group is being placed in a less advantaged situation and median will be reached without adding any more to this group than necessary to preserve the integrity of the trial. Best wishes.
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