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Re: rickstereo3333 post# 33648

Friday, 11/04/2022 3:37:21 PM

Friday, November 04, 2022 3:37:21 PM

Post# of 36577
Well let's hope that mf gets it right this time. This is precisely what tripped up RLFTF. They redid the primary endpoint towards the end of the P3 trial. The FDA approved it. But in the end they still did not 100% meet the 'primary' endpoint, even though they performed very will with the 'secondary' endpoints. The FDA rejected them because they missed the primary. The FDA could care less about the secondary endpoints even though the secondary can demonstrate great safety and efficacy.

This is very risky business when you are working with the FDA. I've always felt that Congress should appoint an oversight committee to ensure that the FDA key decision makers are 1) competent 2) not corrupt. IMO the lucrative PDUFA fees seriously bias (and corrupt) the FDA in their decision making. Last year Project Veritas recorded an undercover video/audio with an FDA decision maker which brought a lot of this to light. It is what it is.