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Saturday, October 23, 2021 11:33:09 PM
Well, if Aviptadil TRULY has a shot at Breakthrough Designation…and personally, I really think it does based on the Science, not personal feelings…the answer regarding the Breakthrough Application must be rendered by 04 December 2021, as per FDA Policy. (The Policy states a determination will be rendered within 60-days of receipt of the application. **See #22 of the FDA’s Q&A Section of their internet site related to Breakthrough Designations.)
So, as long as Neuro did in fact file the Breakthrough Designation Application on 04 October 2021, as we were all told it was, then how much sense would it make to withhold the EUA determination, only to provide a potential affirmation of Breakthrough status?
I know…the going out on a limb bit is definitely “that” since I’m using the assumption that Breakthrough Designation is highly probable. But based upon the evidence…it truly IS probable.
Time will bear it all out though.
—Cheers—
~ Brian A, Y@h00 RLFTF finance conversations
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