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Re: Hondo44 post# 163753

Wednesday, 08/09/2023 12:49:20 PM

Wednesday, August 09, 2023 12:49:20 PM

Post# of 180558
How would I know MK omitted a critical consideration like genotoxicity in draft IDE application? In any case, had MK not taken over a year to respond to FDA comments on first draft IDE application, the error would have been resolved much sooner. But here we are months after FDA flagged the issue before April meeting (Yes, it's all there for anyone who bothers to read RDGL updates. There was no surprise at April meeting.) and due to incompetent MK's continued resistance and foot dragging, the matter drags on. Heck, we don't even have confirmation RDGL has submitted the draft genotoxicity protocol yet! But MK has time to put out a meaningless pr about hopeless money losing IsoPet!

The sooner MK is fired, the better for all longs.
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