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Re: foxhound02 post# 3919

Sunday, 02/02/2014 1:41:35 PM

Sunday, February 02, 2014 1:41:35 PM

Post# of 700556
Yes, of course the primary end points were set. The dmc does not simply examine the stats to make their decision. That is the point of the last conversation. The guidelines also have them looking at need, subgroups (which may or may not have specific end points), they may or may not take into consideration external data like a really good safety record in their compassionate use program, etc. Stats are absolute for the end points and are the primary tool, but if you read the regs and interviews with former DMc members from extensive surveys, you'll know the primary and secondary end points and p values are not the only factors they consider. It's a bigger job than that.
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