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georgejjl

02/08/24 6:30 PM

#451387 RE: ignatiusrielly35 #451385

ignatiousrielly, I agree.

The FDA can be given a copy of the pre-published peer reviewed article after they have signed an NDA (nondisclosure agreement) agreeing that they cannot disclose the contents of the article until it is published either online or in print.

Good luck and GOD bless,
Bullish
Bullish

crescentmotor

02/08/24 7:12 PM

#451394 RE: ignatiusrielly35 #451385

The FDA may be reviewing it [peer review article] in prep for a meeting.



I don't believe examining a peer review article is an integral step of the FDA's trial review process.