TurdBlossom..thanks. I've posted the entire Q&A for the question here (from their web site). They sure bury those FAQs deep down in the site.
When do you expect FDA-approvals for either the intravenous or inhaled formulations?
We cannot speculate on the likelihood or timing of FDA approvals. Day 28 top-line results from the U.S. Phase 2b/3 trial with the IV formulation of RLF-100™ were announced in February 2021. We anticipate longer term day 60 data to follow in March. It is possible that the FDA could grant Emergency Use Authorization (EUA) based on these results. A full New Drug Application (NDA) requesting marketing approval could also be submitted at a later time, based on positive top-line results and including full chemistry, manufacturing and controls (CMC) data as well as additional information on the profile of the drug from other previously conducted clinical and preclinical studies. The FDA granted RLF-100™ Fast Track designation, which, among other things, makes RLF-100™ eligible for Priority Review if relevant criteria are met. Priority Review designation means the FDA’s goal is to take action on an application within 6 months compared to 10 months under standard review. It would be reasonable to expect Priority Review for applications filed under the Coronavirus Treatment Acceleration Program (CTAP). RLF-100™ is part of this program, which was promulgated by the FDA in 2020 in express response to the emergence of the COVID-19 pandemic.
The U.S. Phase 2/3 study with the inhaled formulation of RLF-100™ was initiated by our partner, NeuroRx, Inc. in February 2021. We cannot speculate on the timing or likelihood of an FDA approval.
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