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Re: F1ash post# 71900

Sunday, 07/31/2016 11:43:16 PM

Sunday, July 31, 2016 11:43:16 PM

Post# of 462734
It amazes me that several posters here still DO NOT UNDERSTAND THE PURPOSE AND DESIGN OF A P2 TRIAL. The FDA guided Anavex in its P2 trial design to be an adaptive, open label trial of 32 patients for the purpose of identifying maximum and optimal dosages, as well as the results from the two study arms: monotherapy and combo with donepezil. There's not supposed to be a larger number than 32 nor a placebo arm. The results of this adaptive, open label P2 will greatly increase the chances for a successful P3, which will indeed be larger (multiple locations) and potentially have a placebo arm, but more likely an SoC arm.
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