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Post# of 700248
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dr_lowenstein

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dr_lowenstein

Re: SkyLimit2022 post# 544946

Tuesday, 12/06/2022 9:27:06 PM

Tuesday, December 06, 2022 9:27:06 PM

Post# of 700248
LOL as I have explained previously that is a process document, ie if you are going to submist such data, here is how to do it No where does it say that data will be satisfactory, in other words no change in policy

This guidance does not
address FDA’s substantive review of the RWD/RWE submitted as part of the Agency’s standard
review process.

THEY HATE ME CAUSE THEY AINT ME

NAILED IT ON EVERY STOCK

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