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EUA and NDA are going to happen now. EUA could be within days, which Dr J meets them this week from what seems to now be more truth than rumor. NDA within weeks, inhaled version data in a few months, FDA approval within the year. All VERY possible with this kind of data. The endpoints had such statistical significance at 60-day I almost fell out of my bed when I woke up!
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.
NeuroRx has announced the commencement of a clinical trial of inhaled ZYESAMI™ for the treatment of patients with moderate and severe COVID-19 with the aim of preventing progression to respiratory failure. NeuroRx has also announced the inclusion of inhaled ZYESAMI™ in the I-SPY clinical trial platform for patients with COVID-19 respiratory failure. The company has signed a clinical trial participation agreement with the National Institutes of Health.
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.
Notice that Aviptadil and Relief Therapeutics are mentioned clearly alongside of this for the first time! This is a good indicator for me personally.
Wait weren’t we supposed to get a PR yesterday with the negative results??...calm down Vanilla. Lay off the CAPS
Great to see...I am hopeful
Black rock, the investment firm. It is publicly available
Black rock owns 98million shares, filing date was TODAY! Boom time
NRX new logo now includes the statement “Bringing Hope to Life”. Today was the first PR it was included in. Hope that is a positive sign
My lord you are quite high on yourself lately Vanilla. Chill out a bit. We don’t need you on the megaphone in order to be educated investors
Lovely times around here
For those that have not seen this yet:
https://covid-survivors.org
Continued brutality
22% interest in this loan...again, if ACER cannot pay back money in 6-months time their assets have potential to become ours...high percent for this type of loan where 60% of revenue also comes back to us...just saying
Fun day so far....
I always knew Vanilla Fitbit was going to get caught
Exactly why it is interesting
From Brian on Yahoo: “Apparently, ACER has filed an S-1 Form with the SEC on 12 March, with the SEC Acceptance Date of 15 March. Not seeing the particular reason why yet. Anyone have any insight?”....
https://www.sec.gov/Archives/edgar/data/1069308/999999999521000934/9999999995-21-000934-index.htm
Hard to say. Hard to ignore the hard upward after hours movement on a Friday in a company we just got connected with for a potential merger move to NASDAQ. We also just took treasury shares out, had a 10M infusion from an investor and are waiting on a rather large data release. Honestly who the heck knows. It certainly adds some excitement that much is certain!
Sorry not fully true but they did work to infuse capital
Acer just received a major cash infusion from the retail public through shares conveyed to them by RLFTF at a cost of .24 PS per press release. That's below the current share price. Once sold, they provide operating capital for Acer. Yup, we paid for it with a drop in share valuation....interesting. Coincidence??
So about that ACER merger?....and the treasury shares? And the healthcare investor?...just saying
ACER blowing UP after hours!!
Doing a quick comparison though, they are an “e-commerce” company with little or nothing having ever been done. We have much greater potential (yes, potential and not yet tangible) things to offer to the world
1:10 gets it to 325M which is just fine for a company on Nasdaq and the potential profit they are about to begin producing
There we go, positive energy
Just posting quick to break up the other posts by V Fitbit...now breathe...ok now carry on please
Exactly. This is not the kind of move that says someone knows something
Doth mine eyes deceive me? Green?
Abbott received and FDA EUA today for another test that detects variation between flu, Covid, SARS...I say this because they were not on the mins today and still got it without formal committee review. Same can happen at any point for us, as happened today for them.
Brutal. All around. Could be a perfect time to release good news, if they do indeed have it
This is the hard part about waiting.
The trademarks that RLF filed can mean commercial process is starting, and they hope to be ready to fully scale 8-10 months out (FDA Full approval timeline aligns to this). Also could mean name change to a company or key product...hhmmmm
New trademarks filed....Filed three days after 2/21, the 60-day date end date.
New trademarks registered by Relief Therapeutics International SA. VIPREL and AVIPREL
https://www.swissreg.ch/srclient/faces/jsp/trademark/sr300.jsp?language=de§ion=tm&id=02947%2F2021
https://www.swissreg.ch/srclient/faces/jsp/trademark/sr300.jsp?language=de§ion=tm&id=02951%2F2021
Well there it is finally...blah blah
No updates to bid/ask yet this morning....odd. News on the way?
Honestly I agree with Fitbit here. These little regional networks aren’t going to cut it. If this is high impact let’s get out there, get noticed, and go on some dates!
Maybe in the same spot. You really don’t know
Did you expect us to be?