..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
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:
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—