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  4. CytoDyn Inc (CYDY) Message Board

RLFTF TRIAL RESULTS I don't understand, why are

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Post# of 153897
(Total Views: 731)
Posted On: 02/23/2021 3:33:30 PM
Posted By: calstang
Re: Jax6002 #79522
RLFTF TRIAL RESULTS
I don't understand, why are results released for RLFTF (up 30% today) and not for CYDY (down 30% in 4 trading days)? (A 60% differential!)

"Multidimentional benefit" What's that? Does that drive a 30% share price rise?
https://www.prnewswire.com/news-releases/neur...33805.html

RADNOR, Pa., Feb. 23, 2021 /PRNewswire/ -- NeuroRx, Inc. announced today that the Phase 2b/3 trial* of ZYESAMI™ (aviptadil, previously RLF-100™) for the treatment of Respiratory Failure in critically ill patients with Covid-19 has demonstrated multidimensional benefit around its prespecified primary endpoint of Recovery from Respiratory Failure with discharge from hospital and ICU (without relapse) by day 28 in patients with critical Covid-19 who were treated with High Flow Nasal Oxygen

Although not envisioned at the start of the clinical trial, High Flow Nasal Oxygen has become the predominant form of treatment in Covid-19 respiratory failure, with mechanical ventilation reserved for those whose blood oxygen levels cannot be maintained on this less invasive modality. The trial was conducted at 10 U.S. hospitals under the direction of NeuroRx in collaboration with RELIEF THERAPEUTICS Holding AG (SIX: RLF;OTCQB: RLFTF). NeuroRx has signed an agreement to complete a business combination with Big Rock Partners Acquisition Corporation (NASDAQ:BRPA).

The clinical trial was originally approved as a 28-day study at FDA's direction. In December, NeuroRx added a 60-day endpoint based on the recognition that the traditional 28-day endpoint adopted in the 1990s for trials in Acute Respiratory Distress Syndrome is not appropriate for critically ill patients with Covid-19, who are frequently maintained in the ICU with advanced technologies well beyond this time point. NeuroRx and other clinical trial sponsors alerted FDA to this trend and yesterday the FDA published formal guidance† changing the required time for measuring the prespecified endpoint of "alive and free of respiratory failure" in critically ill patients to 60 days. Interim data are being reported because they were unblinded as per the original protocol and the last patient in the trial reached day 60 yesterday. Therefore, study conduct cannot be adversely influenced by release of these interim findings.


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