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Re: MXAMDUD post# 234661

Tuesday, 07/17/2018 11:21:44 AM

Tuesday, July 17, 2018 11:21:44 AM

Post# of 403025
The FDA requires phase 3 drugs be manufactured at the same facility as that to be used after approval. If not, then there is a delay as the fed will require a CMC and cGMP review before final market approval. Having manufacturing and packaging in place for phase 3 avoids that delay.

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