Relief Therapeutics (OTC: RLFTF) to get FDA approval

Relief Therapeutics (OTC: RLFTF) is the talk of the town on Wall Street. It continues to rise up the charts and emerge. The company is developing a drug candidate RLF-100 for Respiratory Failure in COVID-19 coronavirus patients. Relief Therapeutics & and NeuroRx has recently submitted their application for Emergency Use Authorization or EUA.

Relief Therapeutics & and NeuroRx, Inc. recently announced the completion of their partnership agreement for the commercialization of RLF-100™ (Aviptadil) worldwide. The two organizations have agreed to share all profits from sales of RLF-100 for all indications related to COVID-19 and potentially other respiratory indications on a global basis.

They have agreed that NeuroRx will lead commercialization in the United States, Canada, and Israel, while Relief will lead commercialization in Europe and the rest of the world. Profits from sales will be allocated to Relief and NeuroRx on a 50/50 basis in the U.S., Canada and Israel, 85/15 (in favor of Relief) in Europe, and 80/20 (in favor of Relief) in all other territories.

The two companies have now taken steps to increase manufacturing of the aviptadil drug substance and are in the final stages of contracting with a fill/finish manufacturer, along with a national distribution partner. By January 2021, Relief and NeuroRx expect to have manufacturing, distribution and logistics capacity in place to deliver sufficient drug quantities to treat 150,000 patients per month with RLF-100. The companies continue to anticipate reporting top-line data from the ongoing randomized, double-blinded, placebo-controlled trial of intravenously-administered RLF-100 before the end of 2020. The trial of inhalation-administered RLF-100 is slated to begin enrollment within the coming weeks.

As part of their agreement, Relief and NeuroRx intend to pursue the issuance of trademarks on RLF-100. NeuroRx shall prosecute such trademarks in the U.S., Canada and Israel, while Relief shall prosecute trademarks in all other territories.

“We are pleased to reach this agreement with NeuroRx, a partner we believe is best suited to ensure rapid clinical development as well as timely and expedient interaction with regulatory authorities in what is likely to be the most important market for the drug, the United States. We are looking forward to collaboratively and productively working together in order to maximize the value of the overall franchise for our shareholders and get this potentially life-saving drug to patients as swiftly as possible.”

Raghuram (Ram) Selvaraju, Chairman of the Board of Relief Therapeutics

Dr. Jonathan Javitt added,

”As the global pandemic continues to devastate families and communities, our small team is encouraged by the early promise we have seen in Sami Said’s scientific legacy and we are working around the clock to bring this drug to patients.”

Jonathan C. Javitt, Chief Executive Officer of NeuroRx

Relief Therapeutics (OTC:RLFTF) & NeuroRx FDA Approval

Last week NeuroRx submitted a request for an Emergency Use Authorization (EUA) with the US FDA for the use of RLF-100™ Aviptadil in patients who are receiving intensive care and who have exhausted all approved treatments. The submission is based on a case-control study that compared patients who were treated with RLF-100™ (n=21) to those receiving maximal standard of care treatment (n=30) in the same ICU by the same medical staff.  Patients treated with RLF-100™ demonstrated a 3-fold advantage in survival, recovery from respiratory failure, and other parameters indicative of meaningful clinical improvement. Hypotension was seen in two Aviptadil patients and was successfully managed with pressors. Diarrhea was seen in 4/21 Aviptadil-treated patients and 3/30 control patients.  The results have been submitted to a peer-reviewed journal.

Should you invest in Relief Therapeutics (OTC: RLFTF)

Shares of Relief Therapeutics (OTC: RLFTF) appear to be a very good investment option, the Money Midnight Indicator is expecting its price to increase considerably in the next several months. The majority of the metrics point to this investment being highly attractive.

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Jay Lorrence
Investor of 12 years and Managing Editor of Money Midnight, a news outlet focused on highly profitable investment ideas and bold underground research.
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