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Posted On: 05/27/2021 3:17:54 AM
Post# of 154002
Request for help
I want to rebut my "expert" friend at the NIH. I told him that the FDA insisted on four doses instead of two. In response, he wrote me:
'I can only go by my knowledge of how the FDA works. It is the sponsor who submits the request for doses, dosage, interval schedule etc to the FDA for their plan; NOT the other way around. So it is a curious statement that you related that the FDA "insisted". '
I believe he's wrong. Can anyone here help me say why he's wrong -- why it was on the FDA and not CYDY that the doses were lowered from four to two?
Many thanks in advance!
I want to rebut my "expert" friend at the NIH. I told him that the FDA insisted on four doses instead of two. In response, he wrote me:
'I can only go by my knowledge of how the FDA works. It is the sponsor who submits the request for doses, dosage, interval schedule etc to the FDA for their plan; NOT the other way around. So it is a curious statement that you related that the FDA "insisted". '
I believe he's wrong. Can anyone here help me say why he's wrong -- why it was on the FDA and not CYDY that the doses were lowered from four to two?
Many thanks in advance!
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