Freak is ever the extreme pessimist, but he has a legit point. FDA is a gov agency. They've got guidelines and "rules" up the wazzu. So many, that even they, themselves, wouldn't be aware of all of them. Don't get me wrong, not trying to cut them any slack. Just the way gov operates (or doesn't operate).
It has little to do with the FDA, more to do with the sponsor. The FDA does not like to get involved in blinded trials, unless something goes very good or very bad. It is for the most part, in the hands of the DMC.
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