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Posted On: 12/04/2019 7:51:41 PM
Post# of 149101
Cytodyn should already have part 2 ready to go for both 525mg and 750mg and can submit either one immediately upon FDA decision.
For the CMC, we will initially be going with our current production partner and for the most part we just need to demonstrate that the manufacturing processes and quality control will not change from the clinical trials CMC.
For the CMC, we will initially be going with our current production partner and for the most part we just need to demonstrate that the manufacturing processes and quality control will not change from the clinical trials CMC.
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