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Re: dude iligence post# 30414

Friday, 11/13/2020 5:56:17 AM

Friday, November 13, 2020 5:56:17 AM

Post# of 44690
November 13, 2020 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief" or the "Company") with its partner NeuroRx, Inc., announced that as of today,
150 patients (out of a targeted enrollment of 165) have been enrolled in the ongoing phase 2b/3 trial of RLF-100™ (aviptadil) for treating respiratory failure in patients with critical COVID-19. Respiratory failure is defined, according to FDA guidance, as the need for intensive care with mechanical ventilation, non-invasive ventilation, or high-flow nasal oxygen in order to sustain adequate levels of blood oxygen. So far, no drug-related serious adverse events have been reported.

There is currently no FDA-approved drug that has shown efficacy in patients who are already in the Intensive Care Unit (ICU) with Respiratory Failure. Although NeuroRx and Relief are optimistic that RLF-100™ will also be effective in treating early COVID-19, the companies have focused first on those patients who have no available therapy and are at the highest risk of mortality. An open-label prospective study in patients with Critical COVID-19 has already shown a nine-fold hazard ratio advantage in both survival and recovery from respiratory failure (http://dx.doi.org/10.2139/ssrn.3665228) with both statistically significant (P < .001). More than 110 patients with similar severity have additionally been treated nationwide under an FDA-sanctioned Expanded Access

https://relieftherapeutics.com/newsblog/relief-with-partner-neurorx-announces-enrollment-of-150-patients-in-phase-2b-3-trial-of-rlf-100-for-critical-covid-19-with-respiratory-failure


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RLF will be listed on the MCSI-Swiss-Small-Cap on 11/30.

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NeuroRx submits request for Emergency Use Authorization for RLF-100™ (aviptadil) in the treatment of patients with Critical COVID-19 and Respiratory Failure who have exhausted approved therapy
Emergency Use Authorization request targets the same population as is currently permitted under FDA Expanded Access Protocol

NeuroRx
Sep 23, 2020, 01:00 ET

https://www.prnewswire.com/news-releases/neurorx-submits-request-for-emergency-use-authorization-for-rlf-100-aviptadil-in-the-treatment-of-patients-with-critical-covid-19-and-respiratory-failure-who-have-exhausted-approved-therapy-301136257.html

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The first report of rapid clinical recovery under emergency use IND was posted by doctors from Houston Methodist Hospital. The report describes a 54-year-old man who developed COVID-19 while being treated for rejection of a double lung transplant and who came off a ventilator within four days.1 Similar results were subsequently seen in more than 15 patients treated under emergency use IND and an FDA expanded access protocol which is open to patients too ill to be admitted to the ongoing Phase 2/3 FDA trial.

Aug 04, 2020
https://www.technologynetworks.com/drug-discovery/news/rlf-100-trial-shows-rapid-recovery-from-respiratory-failure-in-critically-ill-patients-with-covid-338232


JMO, maybe, maybe not.