Jake wrote: I could not find a precedent for the a
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Quote:
I could not find a precedent for the agency requiring a biotech to start over in demonstrating the safety of a drug which had already completed multiple trials in various phases.
I think it depends on which model of unpleasantness the FDA is actually based upon. One theory (the conspiracy one, in which the FDA and BP are clamping down on Leronlimab because they actually believe it WORKS) sees the FDA and its works as evil, period. Another theory sees little morality in their actions, but simply bureaucracy at its finest: this theory would suggest the people at the FDA are bureaucrats going through each and every motion, not guided by evil, but guided by the book.
Bureaucrats would not create the precedent that Jake suggest would be necessary to make us begin all over. Bureaucrats are about following the book to the letter, not writing the book.
Evil folks, however, are happy to do what they need to do to have an effect. Evil sometimes requires a little artistic invention.
I'd suggest they are more likely to be bureaucrats. But what about that public letter, calling out CYDY for falsely promoting the results of CD10 and CD12? Wasn't that unprecedented? (Please allow the FDA to introduce themselves: they are men of wealth and taste....)