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Joe.. I do somewhat (not entirely) question the credibility of that web site. I have two next door neighbors who are Covid Nurse Practitioners at two different hospitals. They have been treating covid patients for over a year now. So I place a quite a bit of weight on their opinions regarding this topic. They are boots on the ground, and they see things first-hand. There is no doubt about the fact that hospitals are currently filled up with predominently unvaccinated people. Another neighbor of mine just returned from the hospital (unvaxed) and she almost died from blood clots.
While I do have some fear about the LT affects of the vaccine, it's pretty clear to me now that the vaccine works for the vast majority of people. Even the flu shot has side effects that causes serious damage to some folks. To me, its all about statistical probability. We each have to make that decision individually.
You are missing the point. No one is attempting to compare any pill to RLFTF (aviptadil) or Remdes. They are IV products.
The point is that the FDA now apparently seeks new EUA applications to include comparison data to existing, comparable drugs that have already been approved. example: Bucillamine vs the Pfizer pill. I would not be surprised if the FDA asked RVVTF to show trial data contrasting the two drugs. The FDA was not seeking comparison data with EUA application 1 year ago. This is speculation on my part (of course).
Bill... Right, it goes all ways. IMO it's all about probability and statistics. The odds of severe LT vaccine side effects compared to the odds of LT damage from natural immunity. Without LT testing we just don't know. It's almost a guessing game.
I believe that since we have well over 1 year of experience with the Pfizer and Moderna vaccines with no substantial side effects (to date), I'm going with the vaccine. Age and preexisting conditions plays a role in the decision too. There is no easy decision, hence the doctors NEED Aviptadil as an option.
PW... links (in chrono order)
EUA Rejection - Nov 4, 2021
https://ir.nrxpharma.com/news-events/press-releases/detail/93/us-food-and-drug-administration-declines-emergency-use
PR addressing the lack of data comparing Aviptadil vs Remdesivir - Nov 29, 2021
https://ir.nrxpharma.com/news-events/press-releases/detail/100/nrx-pharmaceuticals-identifies-significantly-higher
New EAU Application (addressing FDA data needs) - Jan 5, 2022
https://ir.nrxpharma.com/news-events/press-releases/detail/107/nrx-pharmaceuticals-submits-emergency-use-authorization
IMO it would behoove RVVTF to address any comparison with the Pfizer pill when they submit their EUA application. RLFTF was surprised by this late-in-the-game FDA request.
I actually tend to agree with that, particularly after someone has received the 3 core vaccine jobs. However how can one get infected and also ensure that it is NOT the deadly Delta that they are getting infected with. Then there is the argument that we don't know the long-term adverse effects of Omicron. Then there is the argument that natural immunity per Omicron may not work against a future variant. It's a slippery slope. We need a great, all-purpose therapeutic like Aviptadil. The FDA needs to get their priorities straight regarding therapeutics.
However, Delta has proven to be deadly (unlike Omicron). So combining the highly contagious Omicron with the deadly Delta does sound scary IMO. A great therapeutic (like Aviptadil) is needed for when the vaccines falter.
DeltaCron (Delta + Omicron) ... the new variant. 2022 is going to be a longggg year.
https://www.mediaite.com/news/deltacron-covid-variant-that-combines-delta-and-omicron-reportedly-discovered-in-cyprus/
RLFTF EUA was just declined by the FDA because the RLFTF study did not 'compare' the RLFTF drug with remdesivir. Is RVVTF comparing bucillamine to the recently approved Pfizer pill? That could end up being a snag for them. Unfortunately, the FDA can change the rules whenever they want.
I hear that the diving there is great!. I'm a diver myself. But is it safe?
Why hasn't RVVTF updated their dates & data for their covid clinical trial. Example: it's showing the study completion date at November 30, 2021.
https://clinicaltrials.gov/ct2/show/NCT04504734?cond=Bucillamine&draw=2&rank=1
Great article!
Pulled this off of FB. This is pretty amazing if you want to read some of the private emails between RAM and Dr JJ.....
https://iapps.courts.state.ny.us/webcivil/FCASeFiledDocsDetail?county_code=zdi%2FX1bCq%2FMkp5ec9OegKA%3D%3D&txtIndexNo=9GS05rSOVXD0k7KnombF5g%3D%3D&showMenu=no&isPreRji=N&civilCase=gHbudcupDuGl10F0rgU01w%3D%3D&fbclid=IwAR2m_9-zBSuRTJ34v7_xG2ngjgrB4fAVRDNbsW122t5ZKQhhLfpzM2DJVDc
I personally do not feel that this is a realistic event unless they get EAU. Until then, the real net worth of aviptadil is a big ?
soliloguy..you may correct that Dr JJ won't slam Remdesivir. However, my thinking is that the mass media will if that comparison data is made public. Let's just keep our fingers crossed that the FDA will give the latest EUA application HIGH priority on their TODO list. For what it's worth.... Dr Joey feels very confident that either they will be granted EUA or eventually receive full NDA approval.
Another theory I just read was NRXP doesn't want to offend BP by calling out the poor showing of Remdesivir (yet) in the PR. Rather leave the 'devil in the details' inside the EUA Application submitted to the FDA to first get the EUA. Then after EUA is granted, then pull out the stops in slamming Remdesivir.
I am a bit puzzled though as to WHY today's PR doesn't make any mention of how well Zyesami performed as compared to Remdesivir. Unless I'm missing something, those facts were left out. Isn't that what the FDA was asking for? It only references Zyesami as compared to a "placebo".
I am a bit puzzled though as to WHY today's PR doesn't make any mention of how well Zyesami performed as compared to Remdesivir. Unless I'm missing something, those facts were left out. Isn't that what the FDA was asking for? It only references Zyesami as compared to a "placebo".
Joe, the more I read what comes out of Dr JJ's mouth, the more I'm inclined to feel that he is going to FIGHT the CA all of they way to a judge or jury. I'm not hopeful that this will be solved through mediation.
I sure hope that RLFTF does not waste too much time trying to negotiate/mediate. I now believe that Dr JJ is stalling to buy time to tie up other lose ends which will make his case stronger in court, or buy him time to secure his personal fortunes. RLFTF should quickly crank up the heat on the law suit immediately after mediation runs into any snags. They gotta 'fight fire with fire'. I think that is the only thing Dr JJ will understand or respect.
Joe..thanks for sharing this!!! I was looking for it on Discord because Joey left a couple of posts over there today, but I must have been looking in the wrong place.
Email from RLFTF to SH. The HEAT is ON. RLFTF is not standing by and letting DR JJ try and claim rights to Aviptadil.
Dear Sir or Madam,
We would like to draw your attention to the following ad hoc announcement pursuant to Art. 53 LR of RELIEF THERAPEUTICS Holding SA:
Relief Reports that its U.S. Collaboration Partner has Announced the Filing of a Provisional Patent Application for Stable Compositions of Aviptadil Suitable for Human Use
Geneva, Switzerland, January 4, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), of its collaboration partner with respect to aviptadil, NeuroRx, Inc. ("NeuroRx") has announced that it has filed a provisional composition of matter patent application with the U.S. Patent and Trademark Office entitled, "Stable, Buffer-free Compositions of Vasoactive Intestinal Peptide (VIP)." According to the press release, the provisional application describes compositions of vasoactive intestinal peptide, the synthetic form of which is aviptadil, that are both shelf stable and biologically active when used to treat COVID-19 and other diseases. The related NRx press release can be accessed through the following link.
Relief notes, in response to a statement in NRx's press release that aviptadil is a 70-year old dormant drug, that aviptadil is an analog of vasoactive intestinal peptide (VIP) originally discovered in 1970, and that Relief and its predecessor companies have been working on the development of aviptadil for almost 20 years. Relief also notes that the formulation of aviptadil being used by NeuroRx, and any intellectual property that NeuroRx may obtain with respect to such formulation, is covered by the parties' collaboration agreement with respect to the development and commercialization of aviptadil, and that under such agreement, NeuroRx is obligated to cross-license such formulation, and all related intellectual property, to Relief. The failure of NeuroRx to cross-license its formulation of aviptadil to Relief is one of the alleged breaches of the collaboration agreement that is raised in Relief's previously filed breach of contract lawsuit against NeuroRx, and its CEO, Jonathan Javitt.
ABOUT RELIEF
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle
Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.
Follow us on LinkedIn.
CONTACT:
RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com
FOR MEDIA/INVESTOR INQUIRIES:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the provisional application filed by NRx will result in the issuance of a patent, (ii) whether RELIEF THERAPEUTICS Holding SA will be successful in its breach of contract action against NRx's subsidiary, NeuroRx, and NeuroRx's CEO, Jonathan Javitt, (iii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19 or any other disease, and (iv) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
I welcome your ability to see the silver lining. Greater oversight on the NASDAQ should help with shorting as well as MM manipulation .. to some extent.
I'm still not convinced though that a 1 for 150 ADR conversion is a whole lot different from a vanilla 1 for 150 R/S. At the end of the day, the outcome of both appears to be nearly the same for the common SH.
So, on the horizon we have several things around the corner. The two inhaler trials, and soon CA mediation talks should begin. January could be a very interesting time for RLFTF.
I base my projections on the timelines that were previously executed (with the FDA) with other COVID pharms.
I've been following RVVTF for a long time, and I raised issues (along with others on this board) that this CEO had a couple of months to prepare for Phase 3 launch, and he chose to sit on the side lines. It took him months to even get started with Phase 3 AFTER the FDA gave the green light. That was a red flag to me that this CEO is heavily biased toward SHROOMS rather than finding a therapy for COVID. And here we are....waiting and waiting....
Even with Fast Track designation, it would take the FDA at least 2 months to evaluate and make a decision on EUA. And we can't forget that AFTER the study is FINISHED, it will take RVVTF a couple of months to pull all of the DATA together, analyze it, and construct/format an EUA application from all of that raw data. This all takes time. Unfortunately COVID has taken a back seat priority to SHROOMS with this CEO. I'm just being realistic here.
JMHO.
I just stated where. IR and OTC. Having said that, RAM still has some open issues / options, that he is not being transparent about (yet).
You stated.....
N O--Post ADR conversion, the .06 SP increases to $9 --N O
So your "N O" is a bit misleading.
While the SP of RLFTF will remain at .06, that won't help anyone if they cannot trade their shares on the OTC. They will eventually have to convert their shares to ADRs and buy/sell on the NASDAQ at the $9 price (with 1/150 of their number of shares). Incumbent RLFTF SH will only be able to trade their OTC shares on the NASDDAQ as an ADR to try and recoup their initial investments. The ADR price will need to rise to very high levels that I pointed out in my previous calcs for the average SH to break even.... which IMO is unrealistic. IMO it will be far easier for the price to rise from .06 to .50 rather than $9 to $75.
Another Risk: RAM would gain very little by conducting massive dilution today at .06. He would drive the pps to sub-penny. However, at Level 3 he can dump shares at approx $9 / share and push the pps down to $4-5, which would of course hurt the SH.
The best thing for the SH IMO is for (prior to ADR Conversion) positive inhaler trial results to bleed over to the FDA decision on EUA. Positive preliminary IV trial results would be even better. RAM also appears to have enough cash to get him to 2023, which should help reduce the risk of more massive dilution in 2022.
Where are you getting your information from? My information is from both RLFTF Investors Relations coupled with a phone call to the "Issues Dpt" at the OTC.
ADRs can be implemented in different ways. RAM has choices to make.
I have been told that once the ADRs are uplisted to the NASDAQ that incumbent RLFTF shares will no longer be available to trade on the OTC. To trade on the NASDAQ most SH will have to pay a fee for the conversion. Once uplisted to the NASDAQ RAM will be free to sell (dilute) ADRs on the NASDAQ.
In addition, RAM still has other options in terms of HOW he wants to move to Level 3 and implement, so the jury is still out regarding HOW and WHAT he does with the ADRs. If he had already made those decisions, he would have documented them in a PR to the SH (which he has not).
Now, I could have been misinformed. There is always that possibility. However, that is the way it was explained to me.
pegs1, I 100% agree with you. I posted the math on this a couple of weeks ago using different scenarios. Moving the pps from .06 to .25 (or .50) would be whole lot easier than moving a $9 price to $37.50 or $75.
excerpt.....
Here is some math to ponder on (assuming a 'today' price of .06):
A 100K SH investment at .50 = 50K
Post ADR conversion, the .06 SP increases to $9 and position < to 667 SH
The SP would need to > from $9 to $75 on the NASDAQ to JUST break even on the original investment.
A 100K SH investment at .25 = 25K
Post ADR conversion, the .06 SP increases to $9 and position < to 667 SH
The SP would need to > from $9 to $37.50 on the NASDAQ to JUST break even on the original investment.
Yes, it's a nice time of the year to spend some of those profits!
Correction...I meant 'no earlier than summer 2022". JHMO
This is falling in line with my original prediction that EUA will happen no later than summer 2022. Based on other covid pharm studies, it will take RVVTF at least 2 months to compile the 'data' starting at the end of Q1-2022, and submit the EUA application. Then give the FDA another 2-4 months to review/approve it. And this is my 'best case' projection. I will wait to go long until after more weak hands are shaken out in the spring of 2022. JMHO
Phase 3 clinical study enrollment completion period is expected in Q1-2022
georgejj - we have a couple of trials that may soon report out an update.
Clinical Trials... What's Next !!!........
Inhaled Zyesami - 144 participants
Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19 (AVICOVID-2)
Estimated Primary Completion: Dec 15, 2021
Estimated Study Completion: Dec 31, 2021
https://clinicaltrials.gov/ct2/show/NCT04360096
Inhaled Aviptadil - 82 participants
Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS
Estimated Primary Completion: Dec 2021
Estimated Study Completion: Apr 2022
https://clinicaltrials.gov/ct2/show/NCT04536350
pegs, unless the tax laws have changed, you can only write off 3K per year. If you take 9K in losses, you can spread the tax write off over 3 years. Many folks are sitting on much larger paper losses than that.
NRXP will not disclose to us specifically what the FDA is requesting. Other than they want to see more patient data, and they want to see aviptadil compared to remdesivir. Does that imply that the FDA is waiting for the Activ-3b primary completion date of Oct 2022, or will preliminary data suffice. NRXP is not being transparent with the shareholders IMO.
Yes, I personally feel we'll see significant price appreciation if EAU is approved...assuming the 1 for 150 ADR process doesn't first wipe us out via RAM dilution. I have a hunch RAM won't do that since that would also ruffle GEM's feathers as well ! JMHO
pegs, unless I'm missing something, we are all waiting for news to be released on one of the following trials. It then begs the question - how would such news affect the previously declined EUA. Will a new EUA application be submitted, or will the FDA reevaluate the last one based on the new data obtained from one or both of these new trials. Keeping in mind that these two trials are 'inhaled' not 'IV'. We may have to wait until spring 2022 for any real results impacting RLFTF.
Clinical Trials... What's Next !!!........
Inhaled Zyesami - 144 participants
Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19 (AVICOVID-2)
Estimated Primary Completion: Dec 15, 2021
Estimated Study Completion: Dec 31, 2021
https://clinicaltrials.gov/ct2/show/NCT04360096
Inhaled Aviptadil - 82 participants
Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS
Estimated Primary Completion: Dec 2021
Estimated Study Completion: Apr 2022
https://clinicaltrials.gov/ct2/show/NCT04536350
Tim will need to dilute. He needs the funds to finance his upcoming FDA trials.
VF..per the study profile patient load is still officially set at 640
https://clinicaltrials.gov/ct2/show/NCT04843761
Nice overview!!
Rand Paul says Fauci is responsible for THOUSANDS of COVID deaths across the US because he 'deemphasized therapeutics' while focusing entirely on vaccines
https://www.dailymail.co.uk/news/article-10350179/Rand-Paul-says-Fauci-responsible-THOUSANDS-COVID-deaths.html
x-ray... can you please refresh my memory. Is Tim's plan to eventually SELL the patents, or use them himself?
U.S. Halts Distribution of Regeneron and Eli Lilly Covid Antibody Drugs Over Omicron Efficacy Concerns
Dec. 24, 2021 7:59 am ET
U.S. authorities on Thursday halted the distribution of Covid-19 treatments from Regeneron (ticker: REGN) and Eli Lilly (LLY), raising doubts over their efficacy against the Omicron variant.
The Food and Drug Admininistration (FDA) and the office of Assistant Secretary for Preparedness and Response (ASPR), in a joint statement said that the data show that “it is unlikely” that Eli Lilly ‘s bamlanivimab and etesevimab administered together or Regeneron’s REGEN-COV “will retain activity against this variant.”
German researchers had previously come to the same conclusion.
Pfizer’s Covid Pill Gets Green Light. Investors Are Starting to Pay Attention to the Stock.
The U.S. bodies noted that sotrovimab, the drug developed by GlaxoSmithKline (GSK.London) and Vir Biotechnology (VIR), seemed to work against Omicron.
Separately, a U.K. government study published Thursday found that Omicron seemed to lead to less hospitalizations than previous variants, even though a booster shot’s effectiveness seems to wane more rapidly than when used against the Delta variant.
European authorities were continuing Friday to warn against the impact of Omicron on their health systems. German president Frank-Walter Steinmeier, in the text of a Christmas speech to be delivered Saturday quoted by German media reports, warned that “the pandemic will occupy us for a long time.”
And U.K. Prime Minister Boris Johnson, in a televised address filmed in front of a Christmas tree, called on Britons to keep being vaccinated. He said people getting vaccinated were doing so “not just for themselves, for ourselves, but for friends and family and everyone we meet,” adding “that, after all is the teaching of Jesus Christ.”
https://www.barrons.com/articles/u-s-halts-distribution-of-regeneron-and-eli-lilly-covid-antibody-drugs-over-omicron-efficacy-concerns-51640350799
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-december-23-2021