FDA panelist blast companies on Non-Inferiority Studies
Isn't Thomas Fleming the bio-statistician that says you often can't tell which drug is better than another because there's rarely a head-to-head competition showing what "really" works? That the "better than current" (or yesterday) method is a slippery slope towards never knowing what's best?
He gets lambasted by investors and companies alike for criticizing potential new drugs undergoing FDA review when he doesn't think they've reach statistical significance in efficacy.
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