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Re: changes_iv post# 42992

Monday, 10/25/2021 1:08:06 PM

Monday, October 25, 2021 1:08:06 PM

Post# of 44690
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