Cytodyn Inc (CYDY): Nader clearly said that they will need n...

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Re: misiu143 post# 28945

Thursday, 09/20/2018 6:31:24 AM

Thursday, September 20, 2018 6:31:24 AM

Nader clearly said that they will need new pivotal - multiple reasons

1. This was not a pivotal trial
2. Dosing was changed from 325 to 550 to 700 mg - this kind of trial does not lock final dosing for approval. This kind of change shows exploration of optimal dosing which is a feature of P2b
3. Seems Nader is not very comfortable efficacy of 525 - he wants to aim high - a 90%+ response rate will seal the deal and give competitive advantage

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