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clock Created with Sketch. 05/10/20
16:20
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Originally posted by stockrock:
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efficacy and safety for treatments intended to treat life-threatening illnesses (CFR 314.125 (c)), and an ODAC vote of 9-1 in favour of efficacy ... for the FDA to land on a decision that goes against both these two very strong mechanisms that are there to allow the FDA to tick off efficacy... then something is not quite right.efficacy . Because if this hard-line stance is an indication of what the FDA are willing to do going forward, then if they were to act consistently ... they'd throw the rule book at MSB at this Type A meeting and not allow MSB to circumvent the process by trying to go to market through accelerated approval by changing the primary endpoint from 28 ORR to survival.
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Your posts in this thread should be required reading for HC holders. They've been thoughtful, well researched and considered, with a lot of good information. I hope I didn't come across as calling you out in my post, because I just jumped on a small part to discuss something I have seen a lot in the past few days. https://hotcopper.com.au/threads/ann-trading-halt.5660357/?post_id=47792615
(20min delay)