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Post# of 822880
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HyGro

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HyGro

Re: hoffmann6383 post# 608921

Thursday, 07/13/2023 2:32:41 PM

Thursday, July 13, 2023 2:32:41 PM

Post# of 822880
Guess you didn't read it. The Guidance requires filing of revised protocols, but nowhere is there any any specification of an FDA approval process. Protocol includes the SAP. Changing the protocol endpoints requires changing the SAP -- they are both changed at the same time and submitted.
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