Friday, November 05, 2021 12:34:17 AM
https://finance.yahoo.com/news/fda-type-meetings-know-210021939.html
We’ve already been here but many forgot. We were here last year when our sample sizes weren’t big enough. We are back here for the same reason.
The difference is now we have I spy and NIH trials to back us up.
~ KevinB, Y@h00 RLFTF finance conversations
With regards to the latest NRXP news release today, I have to wonder whether the recent ex RLF directors commentary have been a major factor here...?
https://investorsprism.com/death-by-fda/
The original RLF owned Aviptadil RLF-100 formulation has already been successfully approved by the FDA REMEMBER.... With the FDA stating that they were even willing to accept the phase 1 data safety trials previously carried out in order to fast track ZYESAMI... So surely this means that the RLF patented Aviptadil RLF-100 has no safety approval issues with regards to FDA EUA APPROVAL...???
There are other products too owned by the 2 new businesses we recently purchased... In addition to the existing drugs for ED and other treatments, all have a safety approval now being available in the market and being used safely by medical practitioners....
So the way I now understand this is that it is a change of heart from the FDA, regards their offer to accept the earlier RLF Aviptadil RLF-100 safety. They are obviously furious about the report link above, calling them out.... DEATH by FDA...???
NRXP DrJJ has therefore now lost the opportunity to get the RLF earlier trials results included, with the FDA now stating that they only have data on 133 patients in the ongoing NIH trials... BUT in addition to this the FDA is also saying that it doesn't have sufficient safety data either, inspite of the most recent update from the DSMB agreeing that the NIH TRIALS will continue with excellent safety levels found and NO SIGNIFICANT SIDE EFFECTS...??
NRXP has also evidently been successful in arranging for an immediate meeting with the FDA however.... So Dr JJ has it would appear an opportunity to still work with the FDA towards getting the extra data to them.
So my question is until we hear back from the FDA following the meeting, we will not be able to actually confirm that the EUA is actually denied. OR that it is still actually under consideration pending the extra data they need...???
As i mentioned beforehand the situation in the UK and EU is in further deterioration with the number of infections /re infections according to the WHO now placing back to the epicentre.... I am now even more hopeful for our therapeutic to get approval here first....
Although I have noticed that it is very difficult to actually post any newsworthy articles online, i think that we are subject to censorship, on YouTube especially....
GLTA LONGS.... I am holding and continuing to believe that the real science here will prevail...
GLTA LONGS....
~ Andrew, Y@h00 RLFTF finance conversations
ECGI Holdings Announces LOI to Acquire Pacific Saddlery to Capitalize on $12.72 Billion Market Potential • ECGI • Jun 13, 2024 9:50 AM
Fifty 1 Labs, Inc. Announces Major Strategic Advancements and Shareholder Updates • CAFI • Jun 13, 2024 8:45 AM
Snakes & Lattes Opens Pop-Up Location at The Wellington Market in Toronto: A New Destination for Fun and Games - Thanks 'The Well', PepsiCo, Indie Pale House & All Sponsors & Partners for Their Commitment & Assistance Throughout The Process • FUNN • Jun 13, 2024 8:18 AM
HealthLynked Introduces Innovative Online Medical Record Request Form Using DocuSign • HLYK • Jun 12, 2024 8:00 AM
Ubiquitech Software Corp (OTC:UBQU) Posts $624,585 Quarterly Revenue - Largest Quarter Since 2018 • UBQU • Jun 11, 2024 10:13 AM
Element79 Gold Corp Files for OTCQB Uplisting, Provides Financial Update • ELEM • Jun 11, 2024 9:25 AM