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CrashOverride

07/12/23 12:59 PM

#608923 RE: hoffmann6383 #608921

I agree hoffmeister
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ilovetech

07/12/23 1:06 PM

#608925 RE: hoffmann6383 #608921

yep, if one keeps feeling the knawing impulse to wonder, where the hell is common sense? Don't bother. You'll thank me later.

ILT
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HyGro

07/13/23 2:32 PM

#609399 RE: hoffmann6383 #608921

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.