Replies to post #25151 on Relief Therapeutics Holding AG (RLFTF)

[Uncle Gee Gee]

The EUA submission is strictly for the IV form to be used on critical patients only (per Javitt), and although we should have enough data, there is technically a small chance they could ask for more... but you are correct... we definitely meet the "safe" requirement (because the FDA has already determined we are safe when we did our initial interim review at 30 patients), and I would imagine we have enough data to meet the "MAY be effective" requirement with that same data (19 out of 21 critical patients survived).

That being said, we could get EUA any day now; although Javitt cautioned it could take 30 to 60 days.

So... it looks like Javitt and team are working backwards... from most critical to least critical, and we could therefore imagine a SUCCESSFUL timeline to look like this...

1) Obtain EUA for IV to treat critical patients
2) Assess results from the 102 interim review - these results could be used to support the EUA request if more data is needed. It could also clearly demonstrate strong efficacy, resulting in a full fda approval (for the IV form only). It should at least demonstrate enough efficacy to continue trials.
3) Full FDA approval is granted for the IV version only, based on either the 102 interim or the 144 final trial results.
4) EUA and/or full FDA approval is granted for inhaler treatment for mild to moderate inhaler form.
5) EUA and/or full FDA approval is granted for preventative use of the inhaler for the general public.

Each step along the way, opens up our drug to larger and larger populations as the drug continues to prove itself. And hopefully... we obtain SOC status for each along the way!