Replies to post #38425 on Relief Therapeutics Holding AG (RLFTF)

[PennyWorld]

What I found interesting is that the FDA lady's first reaction to my use of the term Aviptadil was... "oh, yes, I've heard of that drug". So the word is getting around.

[go_wamu]

Penny !
Thank you for your prompt reply ! Now I'm informed best.
... and now it's me to send you an email from RELIEF and I hope I've translated well, so that you are able to read it well too. It's not clear from the German text also, whether NeuroRx has submitted an EUA or not. As far as I can judge, they need the data from the U.S. Phase 2b/3 trial only, for approval by the EMA. From another article I learned that their partnership with AdVita is so successful that they are now researching more in this direction, while NeuroRx is supposed to take care of the EUA.
I regret my short answer in post# 38350. Nevertheless, you should take note of the following:

E-Mailed from: Relief Therapeutics <[e-mail]>
Sent: Thursday, April 15, 2021 07:04 EMT
(Quote in excerpts)
Outlook for 2021:

Relief expects to make continued progress with its development programs and in advancing its business in the months ahead.

Pipeline

Looking first to RLF-100 (IV), as our partner NeuroRx executes plans to file for EUA for the treatment of critically ill patients with COVID-19, followed by an NDA, Relief is preparing for clinical assessment and potential commercialization in Europe and other territories. Once Relief has received and analyzed the full data set from the U.S. phase 2b/3 trial, the Company will decide on the best path forward for the development of RLF-100 in Europe and other territories.

Turning to RLF-100 (inhaled), the acquisition of AdVita is expected to close in Q2 2021. Additionally, Relief is hopeful that its partner NeuroRx will have results from the ongoing U.S. phase 2b/3 trial evaluating inhaled RLF-100 in H2 2021.

Our second late-stage program in collaboration with Acer Therapeutics for ACER-001 is expected to progress quickly in 2021. A pre-NDA meeting is scheduled to occur between Acer and the FDA in Q2 2021 to discuss the results of the clinical study of ACER-001 in UCDs. Provided no additional data are requested by FDA during the meeting and ongoing development activities are successfully completed, Acer expects to submit a 505(b)(2) NDA for ACER-001 for the treatment of UCDs in mid-2021, with a potential regulatory decision in H1 2022. Relief plans to initiate discussions with European regulatory authorities regarding ACER-001 in UCDs in Q3 2021. Clinical studies in MSUD could start later in 2021.

Relief plans to continue its strategy to aggressively pursue opportunities to expand its pipeline with attractive late-stage clinical assets that would drive the evolution of the Company into a mature, diversified biopharmaceutical company.

Have a nice weekend !