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mc67

10/25/21 12:16 AM

#42994 RE: changes_iv #42992

..just went to look for an interview where Mark Levin has w/a Yale Dr who spanks BP and the FDA but it was blocked on you-tube.. man talk about control.. maybe (after BP/FDA get enough of those .09 shares they'll come and say we have it Zyesami.. the great.. or they'll just continue on w/the unsafe pill and keep $$ over lives.. who knows at this point but we all bought in (in part) believing in the goodness of man and it turns out they're not good. IMO

changes_iv

10/25/21 1:08 PM

#43003 RE: changes_iv #42992

So, the Application for Breakthrough Therapy Designation was submitted to the FDA on 27 September 2021. That would make the end of the 60-Day review period approximately 27 November 2021.

However, Dr. Javitt reiterated a statement made by Dr. Woodcock (FDA Acting Commissioner) at some point in the past, that the review period could take longer than 60-days due to the current work-load of FDA Staff. I do remember her having made this general statement regarding all FDA activities and reviews. I just don’t have a link to it at present.

Here’s a Link to Neuro’s “actual” Breakthrough Therapy Designation Application:

https://www.nrxpharma.com/wp-content/uploads/2021/10/Aviptadil-BTD-Sept-27-2021.pdf

Here’s a Link to Dr. Javitt’s CEO Update:

https://www.nrxpharma.com/

Anyway, I would like to say “Thank You!” to Dr. Javitt for the CEO Update on the Neuro Website, and for posting a Link to the actual Breakthrough Application. Greatly appreciated!
—Cheers—

~ Brian A, Y@h00 RLFTF finance conversations