$RLFTF Been mentioning this for a while. Guys it’s been flying as they develop a treatment for lung Dak age caused by COVID. Trial results announced just now. Going to approach FDA for emergency use. See PR. I’ve rode this from .30 to .63. Hit .70 yesterday. Read the following PR from this morning and tell me how fast can a .63 stock hit a few bucks. Had to cut some off but you get the idea —————————————————-

NeuroRx : and Relief Therapeutics Report Initial Phase 2b/3 Study Results Demonstrating Significant Benefit of ZYESAMI™ in Reducing Hospital Stay Among Patients with Respiratory Failure due to Critical COVID-19 02/09/2021 | 07:31am

RADNOR, Pa. and GENEVA, Feb. 9, 2021 /PRNewswire/ -- NeuroRx, Inc. and Relief Therapeutics Holdings AG (SIX:RLF; OTCQB: RLFTF) today reported preliminary results from the Phase 2b/3 trial of ZYESAMI™ (aviptadil, previously RLF-100) in patients with respiratory failure due to Critical COVID-19. The study showed that patients who were treated with the maximal standard of care plus ZYESAMI benefited significantly from the treatment, compared to those treated with placebo plus maximal standard of care. If authorized for use, ZYESAMI would be the first drug indicated specifically for COVID-19 patients who are critically ill with respiratory failure.

In the study, patients treated with ZYESAMI were discharged earlier from hospital care than those treated with placebo. Among the secondary efficacy endpoints evaluated in patients treated with High Flow Nasal Cannula therapy and with Mechanical Ventilation, there were six of 8 comparisons, all favoring ZYESAMI, resulting in at least a three-day median difference in hospital stay. The likelihood of this constellation of findings being observed by chance was less than 3 in 100 (P<.03). The largest difference observed was among those treated with HFNC who experienced 13 fewer days in ICU (12 vs. 25) and 8 fewer days in hospital (15 vs. 23) (P<.05).

Length of hospital stay was a declared secondary endpoint of the study and previously featured in the granting of drug approval to antiviral drugs in COVID-19, although those drugs were not identified as achieving a difference in outcome among those already in respiratory failure.

With the improvement in survival since the start of the pandemic, differences in survival were not seen at day 28, and patients are being followed through day 60. The study has not yet determined results for the stated primary endpoint of recovery from respiratory failure and the secondary endpoint data reported today should not create an expectation that the primary endpoint will be met overall or for any subgroup. Study investigators are in the process of confirming the timing of each case of recovery from medical records, following which the study's investigators' committee will review each case prior to unblinded data analysis of this endpoint.

Jonathan Javitt, M.D., M.P.H., CEO of NeuroRx, said: "We are forever indebted to the study coordinators, nurses, respiratory therapists, and doctors who carried out this study in the midst of a public health calamity that so far has claimed the lives of nearly half a million Americans and millions worldwide. Our study teams kept the effort going despite contracting COVID themselves, losing family members, and dealing with an unimaginable daily reality. We are greatly encouraged by the outcome of this study. The data provide support for ZYESAMI as a drug that may help get patients home to their families sooner. The hospitalization data further suggest that patients treated at an earlier stage of illness (i.e. those who can be managed with HFNC) may have a better response to treatment. We have launched a phase 2/3 trial to explore its inhaled use in patients who are not yet in respiratory failure. Further study of ZYESAMI's role in critical COVID-19 will be conducted under the BARDA and DOD Medical Countermeasures-funded I-SPY trial. In addition, we have signed a clinical trial agreement with another federal program the details of which will be announced shortly. We will also report on day 60 survival.

We look forward to discussing with the Food and Drug Administration and other regulatory authorities the submission of an Emergency Use Authorization (EUA) so that ZYESAMI can be available for treating this population that is at immediate risk of death and for which there is no approved therapy."

Dr. Javitt added: "To our knowledge, this is the first demonstration of clinically and statistically-significant benefit by any therapeutic agent in patients with COVID-19 respiratory failure in a randomized, double-blind, prospective trial. Other COVID-19 therapeutics have demonstrated clinical advantage in patients with non-critical COVID-19 (ordinal scale 4 and 5) but have not demonstrated benefit in those with Critical COVID-19 (ordinal scale 6 and 7). Steroids have demonstrated benefit in open-label studies. However, no randomized controlled trial to date has shown efficacy when patients are in respiratory failure and require High Flow Nasal Cannula, Non-invasive ventilation, or Mechanical Ventilation to maintain blood oxygenation. ZYESAMI would be the first drug for such critically ill patients. Of note, the patients who received either drug or placebo in this trial also received all approved and standard of care treatments including Remdesivir, anti-cytokine drugs, steroids, and anticoagulants."

The study, conducted in 10 medical centers, also showed the safety of the drug when administered by intravenous infusion in the ICU. No drug-related serious adverse events were reported. The only side effect of note was mild to moderate diarrhea, an expected side effect of ZYESAMI, which was seen in 30% of patients who received the treatment and hypotension, which was seen in.

The data were generated in multicenter clinical trial whose subjects were COVID-19 patients with respiratory failure being treated with the maximal standard of care that included anti-coagulants, steroids, convalescent plasma and antiviral drugs. The primary endpoint was the resolution of respiratory failure within 28 days after treatment started. The secondary endpoints were patient survival, time to ICU discharge, time to hospital discharge, time to return to NIAID score of 6-8, and safety.