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Re: Doktornolittle post# 65925

Saturday, 07/02/2016 6:49:36 PM

Saturday, July 02, 2016 6:49:36 PM

Post# of 730234

I think it is a possibility. It really doesn't make much sense for the FDA to have suggested that solution given that PFS as primary endpoint had risks. Risks that the FDA was fully aware of. Again, this is similar to saying; we think your high wire act is too risky, but you have chosen to go ahead with it, and you are not selling enough tickets, so we strongly suggest that you remove the net so that you can attract a bigger audience.


I'm generally not a fan of conspiracy theories, but it's entirely within reason to accept the possibility of interference inside the FDA by Big Pharma companies. There are scientist on various FDA committees with Big Pharma associations; Big Pharma pays a lot in user fees; and Big Pharma is very influential on the Hill.

Be interesting to hear the perspective from someone with FDA experience.
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