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Re: Vanilla Fitbit post# 39542

Monday, 05/17/2021 6:48:59 PM

Monday, May 17, 2021 6:48:59 PM

Post# of 44690
Completing the CT during COVID was tough and probably why their attempts to apply for EUA from Interim data. That was Reasonable attempt to expedite things, but the FDA... Expanding to 196 patients must have been tough also. That all is 'successful' history now with the CT being completed.

The FDA was busy granting BP apps even with incomplete data and Safety issues. $ was talking louder, IMO.

It seems the cooperative efforts of NRX/RLf have provided enough Data Now to make a Strong application. Certainly it's time to pass ALL Completed Data and reviews to RLF and move forward on EMA applications.
I would say RLF/NRX has completed the Newest FDA guidance for the RLF-100 IV formulation that the CT was designed for. The new formulations of RLF-100 for Inhalers and extended shelf life may be affected by the posted FDA Guidance as they move forward from Phase 2.
Acer may also benefit, IMO.

https://finance.yahoo.com/news/acer-therapeutics-reports-q1-2021-200100894.html