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Re: steve2150 post# 43726

Wednesday, 05/08/2024 10:02:25 AM

Wednesday, May 08, 2024 10:02:25 AM

Post# of 43764
No mention of accelerated approval, but they could be sitting on that maybe.

FDA guidance recommends that confirmatory trials be underway at the time an accelerated approval is granted. But since guidance does not carry the force of law or regulation, the FDA has limited leverage to ensure the trials are initiated at that time
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