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Re: Gus McCrae post# 414965

Thursday, 11/04/2021 1:13:43 PM

Thursday, November 04, 2021 1:13:43 PM

Post# of 701758
The Lancet article and FDA draft guidelines on external arms should be a clue it’s not the FDA’s stance on endpoints causing delay. If that wasn’t enough, then perhaps the real world data draft guidelines just published would win your confidence. No? How about the head of Orbis saying any new SOC needs capacity for rapid manufacturing expansion. No? How about the MHRA caseload delay? I mean, the endpoints? You think this wait is still on endpoint acceptance? Come on, they locked the data a year ago. That’s when you go with the endpoints.
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