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exwannabe

05/22/24 10:34 AM

#693204 RE: dennisdave #693163

At a minimum we know as a hard fact that an efficacy IA was performed prior to the endpoitnt change.

The FDA says that changing the endponts based on information from the trial is a big no-no. And the results of an IA is huge wrt the likelyhood f the initial endpoints failing.