Cytodyn Inc (CYDY): the FDA will approve the p3 adjunct tria...

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Re: Redyu post# 7517

Friday, 11/18/2016 11:34:21 AM

Friday, November 18, 2016 11:34:21 AM

the FDA will approve the p3 adjunct trial with only 30 patients AND enough data for the safety part of the approval. The FDA has not said how many patients are needed for the safety aspect but it is assumed that it is more than 30. the P3 mono trial is 300 patients and if they can get enough safety data from the 300 patients earlier than the completion of the p3 mono trial then the p3 adjunct trial will have FDA approval.

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