FDA Lets NeuroRx, Relief Therapeutics Test RLF-100 in COVID-19 Patients (Aviptadil)

https://www.nytimes.com ^ | 08.06.2020 | By Reuters

[rxsid]

FDA Lets NeuroRx, Relief Therapeutics Test RLF-100 in COVID-19 Patients

ZURICH — The U.S. Food and Drug Administration has granted NeuroRx Inc Investigational New Drug (IND) permission to test RLF-100 (aviptadil) for inhaled use in patients with moderate and severe COVID-19 to prevent progression to respiratory failure, it and partner Relief Therapeutics Holdings said on Thursday.

...

They said aviptadil is shown as the first COVID therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes while also preventing synthesis of cytokines in the lung. ... has been granted FDA fast track designation, FDA emergency use IND authorisation, and an expanded access protocol.

[SauronOfMordor]

Under FDA regulations, they can only fast track a drug if there is no already existing effective treatment.

If HCQ was recognized as effective, it would torpedo the approval process for all these expensive drugs.

[Pocketdoor]

Relief Therapeutics Holding AG (RLFTF)
Other OTC - Other OTC Delayed Price. Currency in USD
Its a Swiss company, listed on the Swiss exhange, and also OTC in US. They also have a US partner NeuroRx who is privately held.

[Lurkina.n.Learnin]

Thanks, I’ll check them out.

[Pocketdoor]

HCQ takes about 10-15 days to recover.... RLF-100 3-4 days
Who said it was going to be expensive? There has been no talk of $$.

RLF-100 shown to deliver rapid recovery from respiratory failure in Covid-19 patients
https://www.pharmaceutical-business-review.com/news/rlf-100-phase-2-3-clinical-trial/

[rxsid]

"Yes, its still under patent. Im not sure about price. Its been around for 18-19 years, so the patent has a year or two left in it. "

They've got a minimum 9 years in the U.S. and a minimum of 5 years in many other developed countries.

What is your IP position for RLF-100™?

"Relief holds a patent covering potential formulations of RLF-100TM in the United States valid until at least July 2029, with extension opportunities up to five years as well as in the EU and RoW (Great Britain, Germany, Turkey, Spain, Switzerland, Netherlands, Denmark, Ireland, Austria, PRC and Mexico) valid until at least 2026, excluding extension opportunities comparable to the U.S."

[Pocketdoor]

Thanks for clarifying that. I was shooting from the hip, and just starting to research it. Are you a stock holder? I’m all in.

[rxsid]

Oh yeah :) Got in early August. It's got a LOT of promise for every phase of the disease. Almost too good to be true in some sense.

Looking forward to Apvitadil playing a major role in getting covid under control to the point where it can aleviate the fear some people have out there and get our lives/jobs/routines/country back on track. Oh, and if this turns out to be a unicorn...well...that would be great too!

[Pocketdoor]

I agree. Any day now! Cure the world and get rich at the same time. Lol

[rxsid]

Oh, and as far as price goes, this is the only clue I've seen from either NeuroRX or Relief Therapeutics:

"PRICING SLIDE AVIPTADIL(RLF-100) IV $9000-$16,000 oper patient. RLF-100 Inhaler NO SET PRICING." That's from a slide shown during the discussion with Dr. Javitt, starting around mark 19:10 in this video: 2020-10-15 Solebury Trout Webcast Featuring NeuroRX Dr. Javitt Speaks on NRX-101 & RLF100 (Aviptadil)

Solebury Trout provides investor relations, corporate communications and market access to private and public companies across industry sectors.

Not the clearest screenshot, but this is from that presentation: