Thursday, April 08, 2021 8:30:24 AM
( Even so it also pushes the timeline for massive gains in shareprice back for another 4-6 more months...)
(see below: II.a.:)
As REMDESIVIR is without proven statistical significance EXCEPT highly toxic - even deadly - side effects it’s use is basically nothing more than a Hail Mary application signaling total capitulation by emergency room and intensive care docs because they have NOTHING else as a therapeutic intervention on hand with patients dying on ventilation and ECMO!!
Obviously it was Team Orange with it's cozy interdependent relationship with campaign donors from GILEAD and it's intimate closed doors hugging sessions with their lobbyists that led to the application for EUA being granted for REMDESIVIR in just ONE (1!) day without clinical data to support it!
Talking 'bout armlength negotiations....
(see below: I.:)
What this really means for me is that Janet Woodcock and the other professionals at the FDA had had enough of the cronies of Trump being pushed ahead of them and being allowed to do damage for personal profits ( just like that Postmaster trying to dismantle the Postal Service even so he holds shares big time in direct competitors of the USPS).
Since it would come across really bad to call "Foul" and raise accusations of corrupt dealings within the agency it is easier and far more effective to directly compare REMDESIVIR with AVIPTADIL and it's already proven superior efficacy :
(see below:II.b.)
.
It is going to blow REMDESIVIR with it's potentially lethal long term side effects right out of the water without raising a direct accusation.
The results will fall back on the feet of those responsible for this reckless EUA simply due to power of gravity
Our problem is that timelapse until this space debris is pulled back to earth and the pubication of the results...
The outstanding positive is that this trial will take place in 8 countries across 3 continents thus basically broadcasting the results to ALL the doctors around the world using REMDESIVIR out of desperation!
In the long run this means that we will have a billion dollar marketing campaign for free because every practicing emergency and intensive care doctor will be informed about the failure of REMDESIVIR at once !
I presume this will be one of the most watched clinical trials world wide!
(And not only by doctors desperate for an effective therapeutic but also M&A specialists
What I am fairly shocked with is the share price decline instead of a break out?!?!
I cannot comprehend how people have missed this game changing news?
With this overwhelming developments we ought to be up above 1,00 SFr respectively 1,1US$ already...
Maybe it is the updated valuation report that RLF management commissioned …
we don't need a Short hitpiece as long as management employs these bashers!
Question is :
how to survive this long with our investment whilst NASDAQ hitting All Time Highs all the time...
Best Regards to All!
References:
I.:
Remdesivir starts 2 Phase 3 Clinical Trials on 26/2/20
Remdesivir Results 29/4/20
FDA Emergency Use Authorization 1/ 5/20
Results Of 2483 consecutive admissions, 342 individuals received remdesivir, 184 of whom also received corticosteroids and 158 of whom received remdesivir alone. For these 342 patients, the median age was 60 years (interquartile range, 46-69 years), 189 (55.3%) were men, and 276 (80.7%) self-identified as non-White race/ethnicity.
Remdesivir recipients had a shorter time to clinical improvement than matched controls without remdesivir treatment (median, 5.0 days [interquartile range, 4.0-8.0 days] vs 7.0 days [interquartile range, 4.0-10.0 days]; adjusted hazard ratio, 1.47 [95% CI, 1.22-1.79]).
The addition of corticosteroids to remdesivir was not associated with a reduced hazard of death at 28 days (adjusted hazard ratio, 1.94; 95% CI, 0.67-5.57).
II.a.:
https://www.prnewswire.com/news-releases/neurorx-announces-zyesami-aviptadil-has-been-selected-for-inclusion-in-nih-sponsored-global-clinical-trial-to-include-aviptadil-and-remdesivir-301262506.html
NeuroRx Announces :
Zyesami™ (Aviptadil) Has Been Selected for Inclusion in NIH-Sponsored Global Clinical Trial to Compare Aviptadil and Remdesivir
NEWS PROVIDED BY
NeuroRx
Apr 06, 2021, 01:01 ET
RADNOR, Pa., April 6, 2021 /PRNewswire/ --
NeuroRx, Inc. reports today that Aviptadil, to be supplied by NeuroRx, has been identified by the National Institutes of Health (NIH) as one of two drugs selected for inclusion in a phase III multicenter clinical trial that will include the United States and multiple foreign countries. Aviptadil is being developed by NeuroRx as ZYESAMI™ in collaboration with Relief Therapeutics Holding, AG (SIX: RLF,OTCQB: RLFTF).
The trial, designated as TESICO (Therapeutics for Severely Ill Inpatients with COVID-19), is funded by the US Government COVID-19 Therapeutics Response and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). The TESICO protocol has been reviewed and approved as a phase III trial by the US Food and Drug Administration and will randomly allocate 640 participants to Aviptadil, Remdesivir, the combination of both drugs and placebo.
Remdesivir is currently marketed as Veklury© by Gilead Sciences (Nasdaq: GILD). The primary endpoint of the trial will be participant recovery from respiratory failure over 90 days. Additional information will be supplied by the NIH when the trial randomizes its first patients.
II.b.:
NeuroRx Announces on March 29th,2021 ZYESAMI™ (aviptadil, RLF-100) Met the Primary Endpoint of Its Phase 2b/3 Clinical Trial and Also Demonstrated a Meaningful Benefit in Survival from Critical COVID-19
Press Releases
CISON PR Newswire
RADNOR, Pa., March 29, 2021 /PRNewswire/ — NeuroRx, Inc. today reports 60-day results of the Phase 2b/3 trial of intravenously-administered ZYESAMI™ (aviptadil acetate) for the treatment of respiratory failure in critically-ill patients with COVID-19, which is being developed in collaboration with Relief Therapeutics Holding AG (SIX:RLF,OTCQB:RLFTF).
Across all patients and sites, ZYESAMI™ met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013) and also demonstrated a meaningful benefit in survival (P = < .001) after controlling for ventilation status and treatment site.
In addition to the robust overall significance across all 196 treated patients at all 10 clinical sites, the prespecified analysis of recovery from respiratory failure is clinically and statistically significant in the 127 patients treated by High Flow Nasal Cannula (HFNC) (P = .02), compared to those treated with mechanical or non-invasive ventilation at tertiary care hospitals. In this group, ZYESAMI™ patients had a 71% chance of successful recovery by day 28 vs. 48% in the placebo group (P = .017) and a 75% rate of successful recovery by day 60 vs. 55% in the placebo group (P = .036). Eighty-four percent (84%) of HFNC patients treated at tertiary medical centers with ZYESAMI™ survived to day 60 compared with 60% of those treated with placebo (P = .007).
To the company’s knowledge, ZYESAMI™ is the first COVID-19 therapeutic to demonstrate advantages in both survival and recovery from critical COVID-19 in a randomized, double-blind multicenter trial. On the basis of these findings, NeuroRx plans to apply immediately to the United States Food and Drug Administration (“FDA”) for Emergency Use Authorization (EUA) and to subsequently submit a New Drug Application (NDA).
Recovery from respiratory failure (without relapse) with discharge from acute care and survival through the observation period was the prespecified primary endpoint specified by FDA for the study, originally intended to be assessed at 28 days and then extended to 60 days based on recently-published FDA guidance. The above analysis includes all 196 participants who were randomized and treated in the placebo-controlled, double-blind clinical trial (www.clinicaltrials.gov NCT04311697) conducted at 10 US hospitals. Treatment with ZYESAMI™ or placebo was in addition to standard of care treatment that included steroids, convalescent plasma, antiviral therapy, anticoagulants, and various anti-cytokine drugs.
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