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panton, I would sure love to be a fly on the wall during Gilead's board meetings. I'm sure Aviptadil has surfaced in their conversations .... considering our drug is competing with their drug Remdesivir in the NIH trials. Buying out the competition is commonly done in the corporate world.
You need to spend some time doing some DD to get up to speed on the current NIH trial, etc.. We should be receiving a read out on/before October. ACER-001 is also in play with a PDUFA date of June 5, 2022. Several things on the burner here.
NIH Trial
https://clinicaltrials.gov/ct2/show/study/NCT04843761
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : April 2023
Skull and crossbones is complete nonsense. That may happen to NRXP over the short-term, but not RLFTF who has a much different game plan and more diversified pipe line.
Per OTC Markets....RLFTF is in excellent standing:
OTCQB Member Since 08/2020
Verified Profile IconVerified Profile 01/2022
12g3-2(b) Certified Icon12g3-2(b) Certified
shoon.. HOW do you propose that we hold them accountable?
Jed-- and that PR that you posted was issued well 'after' the SEC investigation announcement. The CEO would not release a fake PR full of lies knowing that he was under serious investigation by the SEC.
So I believe that they are still actively pursuing the same agenda, however clearly the cost cutting strategy has slowed down their progress. Hence raising working capital via dilution with such a small PPS is hurting their financial statements.
So if they don't put the SEC investigation behind them by mid/late summer, and they don't make progress with some sort of deal (ex: Mexico or DR), then I'm sure that we'll see a nasty R/S late summer or early fall.
RVVTF has had a nice price recovery!
Employee Layoffs....they actually may be trying to cut costs in order to survive.
Nice PPS bounce today!
What Biotech Investors Must Know Before PDUFA Dates
https://investmentu.com/one-day-gains-of-up-to-74-percent/
June 5, 2022 PDUFA.
Crowd-Sourced Web site for significant stock events (Catalysts). It's free.
Click JUNE at the top to see June 5, 2022 PDUFA date for ACER
Then click event for details.
Alerts can be set up, etc.
https://www.catacal.com/calendar
June 5, 2022 PDUFA.
Crowd-Sourced Web site for significant stock events (Catalysts). It's free.
Click JUNE at the top to see June 5, 2022 PDUFA date for ACER
Then click event for details
Alerts can be set up, etc.
https://www.catacal.com/calendar
Unless there is a 'deal' made resulting in revenues, I see a very nasty R/S by this summer or in the fall. Quickly resolving the SEC investigation to the favor of QNTA would be a great starting point.
And nothing in it regarding an R/S, which is somewhat encouraging.
Changes, I've run across a variety of rebuttals related to the graphene claim. That's the problem. Too many arguments from both sides. Here is one from Reuters Fact Check team
https://www.reuters.com/article/factcheck-grapheneoxide-vaccine/fact-check-covid-19-vaccines-do-not-contain-graphene-oxide-idUSL1N2OZ14F
Changes.. FYI - the more I read about the 'graphene oxide' claim, the more I see that the claim has been debunked by scientists.
JK.. to add to your assessment, per their CA, RLFTF will share in the profits from ACER-001. The June 5, 2022 PDUFA event will be the catalyst !
Acer will retain development and commercialization rights in the U.S., Canada, Brazil, Turkey and Japan. The companies will split net profits from Acer’s territories 60%:40% in favor of Relief. In addition, Relief has licensed the rights for the rest of the world, where Acer will receive from Relief a 15% royalty on all revenues received in Relief’s territories.
The CA:
https://relieftherapeutics.com/newsblog/relief-and-acer-therapeutics-sign-collaboration-and-license-agreement-for-worldwide-development-and-commercialization-of-acer-001-for-the-treatment-of-urea-cycle-disorders-and-maple-syrup-urine-disease
https://seekingalpha.com/news/3822571-acer-relief-report-data-showing-bioequivalence-of-acer-001-versus-reference-drug
Acer, Relief report data showing bioequivalence of ACER-001 versus reference drug
Apr. 12, 2022 5:56 AM ETAcer Therapeutics Inc. (ACER), RLFTFBy: Ravikash, SA News Editor
Medical Science Laboratory with Diverse Multi-Ethnic Team of Microbiology Scientists Have Meeting on Developing Drugs, Medicine, Doing Biotechnology Research. Working on Computers, Analyzing Samples
gorodenkoff/iStock via Getty Images
Acer Therapeutics (NASDAQ:ACER) and Relief Therapeutics (OTCQB:RLFTF) said data from two phase 1 studies showed that taste-masked sodium phenylbutyrate (ACER-001) was bioequivalent to sodium phenylbutyrate (BUPHENYL(R)) powder under both fed and fasting conditions.
The company has filed an application with the U.S. FDA seeking approval of ACER-001 for Urea Cycle Disorders (UCDs). The FDA is expected to make a decision by June 5.
The companies presented the data — which evaluated the bioavailability, bioequivalence and taste attributes of taste-masked ACER-001 compared to sodium phenylbutyrate (BUPHENYL(R)) — at the Society for Inherited Metabolic Disorders Annual Meeting.
The companies added that higher levels of phenylbutyrate (PBA) and phenylacetate (PAA), a conjugate base of phenylacetic acid, were seen when taste-masked ACER-001 was administered under fasting versus fed conditions. A similar reduction in the PK of sodium phenylbutyrate (BUPHENYL(R)) powder under fed conditions was seen between the fasted and fed studies.
Adverse events in the studies showed no major safety signals.
In addition, the companies noted that results from two phase 1 taste assessment studies concluded that taste-masked ACER-001 was shown to have overall lower flavor intensity scores than sodium phenylbutyrate (BUPHENYL(R)) powder when administered within five minutes of preparation.
changes... that first video is VERY SCARY. Thanks for sharing. Geometric structures found in vax'd blood. And they move and they shine near an active cell phone. My son has a degree in molecular biology, and he'll be studying the 39 min video. Hopefully it doesn't turn out to be doctored pictures and fake news. Well, actually I hope it is all fake!
Headline...I would have preferred a headline stating that EUA was approved. VERU still has a long row to hoe. They need to construct the EUA application from their data and submit to FDA (1-2 months). Then the FDA will review and make a decision (1-3 months). And that assumes no mishaps along the way. So, VERU is behind NRXP regarding EUA processing.
grove...where is the pump? Aside from the typical annual report, the last PR was back in 1/19/22. So where is this pump you speak of?
JK...very, very true. However, if mediation prevents the law suit from going to the courts, it does give NRXP a more favorable chance. I suspect that one of the primary reasons why the SP NRXP is in the tank is due to the existence of the law suit. But the market is fickle, so no one knows for sure what the outcome would be if both parties resolved their differences without going to court. NRXP has a new CEO, so they may be starting from a new, clean slate.
choo, Progress with median has been reported!! If RLFTF and NRXP finally come to amicable terms via mediation, we could see a total turn around in SP for both entities. The NIH trial is driving the success/failure of RLF-100/Zyesami.
Report, I've been following this stock for 2 years. Early during covid I was long in it. It was after I concluded that this CEO is obsessed with shrooms that I got out at near B/E (with a slight loss). He had no sense of urgency with the covid phase 3 trial. It became obvious when 90% of the PRs were about "shrooms", and not about phase 3 progress. Once the trial is complete, one can easily add 6-9 months for him to collect the data, analyze, submit EUA, and WAIT for FDA to review it an approval. No sense of urgency with this CEO. When if the pps dips under .05, I may get back in.
Rick. the other oinker Relief just moved to Level 1 ADR. Once at level 3, they will be uplisting to the NASDAQ. O/S for their new ADR symbol will be very small. That's how they are are handling that catasrophe.
I think JJ is in damage control mode across the board. He's sitting with a very week hand (legally). And he's had very bad luck with EUA, so I doubt he wants to be a bag holder IF the FDA rejects the 3rd EUA (no matter the reason). JJ is like a rat caught in a corner with no teeth. No telling what he will do. If zyesami collapses, then so does he and his corporate house of cards (NRXP). If mediation proves to be successful for both sides, then I suspect that we'll see a boost in PPS for both sides.
We are going to need a congressman to exercise the FOIA to disclose his vested interests in the vaccines that Fauci was promoting. That needs to be done to shed light on whether Fauci did or did not have a conflict of interest. The fact that Fauci refuses to disclose the information tells all.
Agreed! We're on the same page. There's been a lot of talk about buyouts. Until trial results are released, that's just wishful thinking.
If they were close to approval, even RVVTF would not know that.... let alone a BP to execute a buy-out. Until the trial results are fully unblinded, outsiders remain in the dark. And as the seriousness of the pandemic winds down in 2022 and 2023, COVID therapeutics slowly lose their high value. JMHO.
skiluc, I tend to agree with your logic regarding patience. However, QNTA needs to hold another CC to update the SH on current events (less the SEC investigation).
skiluc, you must admit though that the bills are piling up and they have to keep diluting to stay alive. So time is not on their side. In 2021 they inserted the R/S clause in their financials, then yanked it due to SH outrage. So we know they have the R/S seed in the back of their mind. The float is ok, but the O/S is now up over 400M. Your thoughts on the R/S risk?
rickster... you raise good questions. I'm becoming concerned with their cash burn, their cash position (I think is < than 10M), and their 320M O/S and float. I'm 98% sure that Michael Frank executed a R/S in a previous position somewhere (I can't locate that link now). Have you done any DD on the risk of an R/S with RVVTF? They have no real revenues, and the bills are piling up fast with the FDA trial.
If QNTA survives the current SEC investigation, I do believe that sub-pennyland will be behind this company for some time to come.
An attorneys' perspective on recent events (today):
Mopar — Today at 3:03 AM
I just read the recent stipulation/order signed by the parties to be effective once the Judge signs it. My interpretation of the stipulation/order:
The stipulation provides (1)for Nrx to turn over certain documents to Rlftf that both parties have agreed that will facilitate an amicable settlement of the litigation; (2)oral arguments hearing date on the two motions filed by Nrx has been deferred for 90 days; (3) automatic deferrals of 45 days shall occur thereafter until one or both parties decides that mediation is no longer progressing towards a settlement and (4) the time clock stops during this deferment period and no rights shall be extinguished or time taxed as to either party due to any time sensitive expirations that may apply to assert them.
I find the introduction paragraphs of the stipulation to be the most telling indication of the posture of mediation. The pertinent part reads:
“WHEREAS, the parties have agreed to attempt to amicably resolve this litigation through mediation;
WHEREAS, the parties have begun mediating and have made progress in said mediation;”
In my opinion the introduction indicates a positive atmosphere now exists in the mediation efforts. They are letting the Court/everyone know that both parties want to amicably resolve this litigation and that meaningful progress has been made by resolving some of the issues of the litigation although there are other important issues left to be resolved. This is great positive news in my opinion although as a wise mentor once told me “don’t count your chickens until the eggs hatch”….and he added until they are fully grown as he was a very wise elderly lawyer. ?? I’m feeling extremely optimistic!!!
*These are just my personal thoughts and not legal nor financial advice to be relied upon in any way for any reason. Opinion Given For Entertainment Only!!!!
I"m sure that JJ is trying to protect his and his family personal assets. If I had to guess, RLFT and RAM are more interested in salvaging their I.P. and make a profit with their investment rather than punish JJ. I'm sure GEM is chiming in on mediation as well. It's just hard to tell where mediation will end with this. If the new CEO opens the NRXP books to RLFTF, provides ALL of the trial data, and attempts to satisfy everything RLFTF is asking for, then maybe this could end nicely for the RLFTF shareholders.
RLFTF still needs NRXP though. If the NIH trials are successful, NRXP will need to take things to the next level. It could happen, but I doubt RAM would swap in a replacement for NRXP to take over. So my guess is RAM doesn't want NRXP to file chapter 11. The smart thing to do IMO is mediate a solution that is a WIN/WIN for both sides....and most likely that means JJ will NOT get away with trying to steal the I.P.
I think these delays work to JJ's benefit. He'll be able to salvage a great deal on his own behalf. However, if it goes to court and the judge rules against him personally, he will pay dearly. JJ won't let it go to court though I'm sure.
JK, my question is ....does the 90 day clause imply that the June 8, 2022 hearing date is now pushed out? They still list that date under "Appearances" though.
Yes, this was posted on 4/1/22 under "Show eFiled Documents" at this link. You have to do a "Party Search" first on "Relief Therapeutics". Great to show some progress.
https://iapps.courts.state.ny.us/webcivil/FCASSearch
They have to dilute to pay the salaries/bills, so at this rate I suspect we'll see an R/S sometime this fall.
DollarSquad..looks like you blew that call. They uplisted to the NASDAQ just 2 months after you made that comment. It is what it is.
Just waiting for the FDA established June 5, 2022 PDUFA!