“The FDA rejected the first two protocols submit
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Posted On: 12/31/2020 10:59:12 PM
“The FDA rejected the first two protocols submitted so I'm not sure Cytodyn was the one that made the decision for all cause mortality.”
This is a question I can’t answer: do BP’s allow the FDA to dictate the protocols of their clinical trials? I always assumed the biotech/BPs designed the protocol and the FDA either approved it or made small recommendations. And I understand small changes, but I feel like the FDA telling a biotech/BP what their primary endpoint should be is overstepping their role.
I’ll use the M2M trial as an example: we know now that the protocol was flawed from the start by allowing patients with lower scores to be included. Wouldn’t that be a flaw the FDA would identify if they influence primary and secondary endpoints? Maybe the FDA knows CYDY is inexperienced and made recommendations? Mesoblast is the only other drug that had mortality as its primary endpoint because the other, I believe, knew how hard it would be to accomplish.
This is a question I can’t answer: do BP’s allow the FDA to dictate the protocols of their clinical trials? I always assumed the biotech/BPs designed the protocol and the FDA either approved it or made small recommendations. And I understand small changes, but I feel like the FDA telling a biotech/BP what their primary endpoint should be is overstepping their role.
I’ll use the M2M trial as an example: we know now that the protocol was flawed from the start by allowing patients with lower scores to be included. Wouldn’t that be a flaw the FDA would identify if they influence primary and secondary endpoints? Maybe the FDA knows CYDY is inexperienced and made recommendations? Mesoblast is the only other drug that had mortality as its primary endpoint because the other, I believe, knew how hard it would be to accomplish.
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