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I’m just going to put these two papers here to cheer you all up. Enjoy! Read the PNAS one first, then read the nature paper in context of the first one.
https://www.pnas.org/content/118/41/e2106634118
https://www.nature.com/articles/s41575-021-00416-6
~ Amanda, Y@h00 RLFTF finance conversations
JJ likely to counter claim for libel, slander, defamation of character. But if he does, he has to prove the allegations against him are false. The court likely to mandate arbitration per clause in the agreement. If both parties want to bring Aviptadil to those who need it they will figure out a way to resolve differences. Nevertheless hard to believe JJ will have the same role given the loss of trust. Lesser role has to be part of any deal. JJ needs to acknowledge that Zyesami is not a separately owned proprietary product though it’s formulation may be, and it is another version of RLF-100 with greater shelf life. So much more can be accomplished if we had a team again. Imagine they both realize what’s at stake if it isn’t resolved quickly. The people they are trying to help with Aviptadil lose and so do they. We all lose. It’s a lose, lose, lose. They have to know this. To salvage it concessions must be made, apologies must be given, and the collaboration restored with the focus on getting Aviptadil to those who need it. Then it’s a win, win, win. So they have two options, and one really isn’t a viable one. It’s got to fix or everyone loses. Someone suggested GEM take action. Hopefully behind the scenes they already have.
~ Mathieu, Y@h00 RLFTF finance conversations
————————————————->
@Mathieu
I do not know if you have read the full lawsuit but if you have not you should.
It is 18 months that Relief have gone through s*** and tried to keep the collaboration running. It is a year since an EUA was sabotaged, and they still tried to keep the collaboration running. I could go on. The worst, and probably the last straw, was that CEO update last week where Dr J was talking about developing other paths for Aviptadil as if it was an NRx product. And it's even worse : NRx even got a loan from Relief because they had liquidity problems, and they still did everything they did (this would be a major negative in a trial by jury for NRx).
"collaboration restored", as you mention it, is unrealistic at this point, in my mind. When Relief says in their lawsuit "we are still aiming to resolve amicably" (or something similar), I would not be fooled into thinking it means back to the collaboration agreement, because they have seen NeuroRx/NRx take no notice of it for more than 18 months, the reading between the lines is that "amicably" means there will be a new collaboration agreement which will include a number of additional constraints on NRx, agreement that everything belongs to Relief, very probably the removal of Dr J as CEO, and more.
Like everyone else I have absolutely no idea of how it will play out, but one thing I do know is what I mentioned yesterday, there are no positives for NRx in allowing it to go trial, particularly a jury trial, which in my mind means that "amicably" effectively means "according to our NEW terms and conditions" !
IlkaS, Y@h00 RLFTF finance conversations
CDC and its partners are actively monitoring reports of myocarditis and pericarditis after COVID-19 vaccination. Active monitoring includes reviewing data and medical records and evaluating the relationship to COVID-19 vaccination.
Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the outer lining of the heart. In both cases, the body’s immune system causes inflammation in response to an infection or some other trigger. Learn more about myocarditis and pericarditis.external icon Seek medical care if you or your child have symptoms of these conditions within a week after COVID-19 vaccination.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html
Inflammation refers to your body's process of fighting against things that harm it, like infections, injuries, and toxins, in an attempt to heal itself. When something damages your cells, your body releases chemicals that trigger a response from your immune system.
https://www.healthline.com/health/chronic-inflammation
Vasoactive intestinal peptide (VIP), a peptide produced by immune cells, exerts a wide spectrum of immunological functions that control the homeostasis of the immune system. In the last decade, VIP has been clearly identified as a potent anti-inflammatory factor, both in innate and adaptive immunity. In innate immunity, this peptide inhibits the production of inflammatory cytokines and chemokines from macrophages, microglia and dendritic cells. In addition, VIP reduces the expression of co-stimulatory molecules on antigen-presenting cells, and therefore reduces stimulation of antigen-specific CD4 T-cells. In terms of adaptive immunity, VIP promotes T-helper (Th)2-type responses, and reduces inflammatory Th1-type responses. Several of the molecular mechanisms involved in the inhibition of cytokine and chemokine expression, and in the preferential development and/or survival of Th2 effectors are known. Therefore, VIP and its analogs have been proposed as promising alternative candidates to existing therapies for the treatment of acute and chronic inflammatory and autoimmune diseases.
https://pubmed.ncbi.nlm.nih.gov/16312132/
According to a new report published by Allied Market Research, titled, “Anti-Inflammatory Therapeutics Market, by Drug Class and Indication Type : Global Opportunity Analysis and Industry Forecast, 2021-2028,” the global anti-inflammatory therapeutics market size was $98,026 million in 2020 and is projected to reach $125,552 million by 2028, registering a CAGR of 4.0% from 2021 to 2028.
https://www.alliedmarketresearch.com/press-release/anti-inflammatory-therapeutics-market.html
Fibromyalgia (FM) is a disorder characterised by soft tissue pain, disturbance of function an often prolonged course and variable fatigue and debility. A clearly defined aetiology has not been described. This paper proposes that immunological aberration is likely and this may prove to be associated with an expanding group of novel vasoactive neuropeptides. Vasoactive neuropeptides act as hormones, neurotransmitters, immune modulators and neurotrophes. They are readily catalysed to small peptide fragments. They and their binding sites are immunogenic and are known to be associated with a range of autoimmune conditions. They have a vital role in maintaining vascular flow in organs, and in thermoregulation, memory and concentration. They are co-transmitters for acetylcholine, are potent immune regulators with primarily anti-inflammatory activity, and have a significant role in protection of the nervous system to toxic assault and the maintenance of homeostasis.
https://pubmed.ncbi.nlm.nih.gov/15082086/
Fibromyalgia Treatment Market size was valued at USD 2961 Million in 2020 and is projected to reach USD 3876 Million by 2028, growing at a CAGR of 3.45. % from 2021 to 2028. The Global Fibromyalgia Treatment Market is expected to grow at a very fast pace over the projection period.
https://www.verifiedmarketresearch.com/product/fibromyalgia-treatment-market/
Massulo52, I agree with your view. Everyone here is rehashing possible strategies in the future of RLFTF and stockholders. I do remember Dr Javitt saying (I paraphrase) AVIPTADIL or the stock is not your average stock. I do agree with Javitt’s assertion. Once EUA is attained, RLFTF share price will start its ascent and other catalysts will propel it higher. I would favor an ACER spac but that’s me. Others may differ and that ok.
I don't see the entire CA canceled because of the lawsuit because the request was to enforce the CA not cancel terms. It would be a better match for RLF holding company to use Acer or one of their current or future acquisitions to handle US business. I guess they could take over NRX and give JJ the boot. Since GEM actually selected NRX for the CA, maybe they recognized then that the extremely limited funds and no real source of revenue would strain NRx to a point that their only solution would be acquisition.
~ CA_Newby, Y@h00 RLFTF finance conversations
Approximately 97% of lawsuits in the U.S. never go to court. They are either settled or dismissed. The question is how much further can the 2 stocks drop before a settlement is reached? (without an EUA) Civil cases settle more often than corporate cases. I would like to buy some more of both, at these SP levels. But, I think holding tight now is my best option...
~ Terry, Y@h00 RLFTF finance conversations
M0tley F00l
This one explanation comes from Nasdaq
Differences between ADRs and "regular" stocks
An ADR can represent a one-for-one exchange with the foreign shares, a fraction of a share, or multiple shares. This is one major way in which traditional U.S. stocks differ from ADRs. This is an important consideration, so let's go through an example.
https://www.nasdaq.com/articles/what-adr-and-how-it-different-regular-stock-2018-10-24
PennyWorld, I do not have a faceb00k account but if Dr Joey Johnson is a doctor in pharmacy this may be the link:
https://m.facebook.com/joey.johnson.9231
Hi MelsDollars, I wonder if my eyesight will be improved by the Aviptadil inhaler???
VIP plays an important role in visual development. Nasal administration of VIP can improve the function of neurons in the LGBd of kittens and has a certain therapeutic effect on amblyopia.
https://bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-019-1203-1
According to the report, the global amblyopia treatment market was valued at US$ 4 Bn in 2020 and is projected to expand at a CAGR of 3.7% from 2021 to 2031.
https://www.biospace.com/article/amblyopia-treatment-market-strabismic-amblyopia-to-dominate-the-market/
An ADR is not a Reverse Split ~ posted by haffernem @ redd1t
Discussion
An American Depository Receipt (ADR) is not a reverse split. Rather, it is more easily thought of as an “IOU,” and allows foreign companies to more-or-less* be traded on US markets, such as the NYSE, via a quote-unquote “loophole” without going through the traditional, lengthy process of up-listing. The process involves a third party, who is eligible to trade on US markets, purchasing shares of the company on foreign markets. This company then writes and lists a receipt (the “IOU”) representing a predetermined certain number of shares, which are traded on the US markets in stead of the actual shares directly. Since the company isn’t being traded directly, the reporting standards are a bit different and somewhat relaxed, although there are still considerable auditing requirements in place. Usually the ADR designation reduces the mandatory filings required with the SEC, although they still have to give at least an annual report. It’s not really a loophole, as the SEC is well aware of it happening and provides support or endorsement. It helps foreign companies, who often have different reporting/listing requirements, have an easier time, and quicker time, being listed in the US.
*As the US markets are buying and selling these IOUs, they aren’t really trading the shares directly, but given as the receipts are standardized (ie: always 5-for-1 or always 50-for-1) they pretty much always represent the actual share price overseas, accounting for exchange rate. For example, if a company has a 5-for-1 ADR receipt, and is selling for the equivalent of $10 overseas, the ADR would be trading at $50 in the US, as it represents 5 shares. I am not aware of any widespread or meaningful arbitrage occurring with ADRs, but this does not necessarily mean it’s impossible - I have relatively limited experience.
A good example of ADRs in practice is the Taiwan Semiconductor Manufacturing Company. (TSMC) While most people think it’s traded directly as TSM on the NYSE, it’s actually trades as a 5:1 (5-for-1) ADR, with the sponsor being CIT Bank. (Not Citi Bank, which can be confusing!) You can see more detailed info about this ADR here:
https://www.adr.db.com/drwebrebrand/dr-universe/dr_details.html?identifier=1228
IIRC, their reports are audited by Deloitte. TSMC is a powerhouse company, literally supporting the modern world through their manufacturing. ADRs, while uncommon, aren’t necessarily a 4-letter word.
However, I do not know the details of Relief’s ADR plans. In fact, I just saw some commotion about it for the first time today on the various message boards, and figured I’d take a quick break from work to chime in. There is some uncertainty, and I felt as though I could provide some useful information. This is not professional advice, I am not a professional trader nor advisor. I do not know if this will make or break Relief’s chances, and only wanted to provide some background info on ADRs. Make sure to do your own research.
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41. In March 2020, Relief's largest shareholder, Global Emerging Markets, suggested that Relief partner with NeuroRx. Relief understood that NeuroRx was interested in collaborating on clinical research in the United States to develop inhaled and intravenous aviptadil formulations for the treatment of COVID-19. Upon information and belief, Global Emerging Markets held an equity interest in NeuroRx at the time in the form of a warrant to purchase shares of NeuroRx at a pre-specified price if the company successfully executed a
public listing of its securities.
-----------------------------———————-
So GEM put forward NeuroRx to Relief.
I imagine that not only they will be part of the solution, in the background, but also that they were fully informed of the lawsuit and support it. Their goal is "money", they have continually and consistently supported Relief through multiple rounds of financing, as recently as last month, which means they believe in the business model of Relief, they have been in full support at every round of what Relief is building, and they are of course satisfied that they will be able to cash in eventually.
GEM are one third of Relief, and only 3% of NRx, so you can be sure of which side they are with. When someone owns 1/3rd of your company, you definitely talk to them before starting a lawsuit against your number 1 contractor, so it can safely be assumed that GEM are in support of it.
It is interesting how this will play out on the NRx side because every single consequence of allowing the lawsuit to proceed is negative, every one : if you cannot produce receipts and continually refuse an audit that could bring you in more money, there are problems that probably can go all the way to Internal Revenue; then there are those who invested in the SPAC; post SPAC investors; there are the Vanguard, Morgan Stanley, Northern Trust; medical licence ?; loss of revenue from everything Aviptadil. I could go on - every consequence of allowing the suit to proceed is negative for NRx, and may even be terminal financially.
So ..... we watch !
~ IlkaS, Y@h00 RLFTF finance conversations
DOES REMDESIVIR NEED A GOOD REPLACEMENT AS SOC???
Zyesami (Aviptadil) COVID-19 Therapeutic
Description
Zyesami (Aviptadil) is a formulation of synthetic human Vasoactive Intestinal Peptide (VIP), which was first discovered in 1970. NRx was the first to formulate aviptadil for human intravenous and inhaled use under the "Good Manufacturing Practices" standards in 2020.
VIP is known to target the VPAC1 receptor of the alveolar type II (ATII) cell and protect that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents. In addition, VIP prevents apoptosis, blocks cytokines, lowers TNFa levels, reverses CD4/CD8 ratio, and reduces cough and dyspnea in nonclinical and clinical studies.
Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and primarily concentrated in the lungs. In addition, VIP has been shown in more than hundreds of peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation says the company.
Because of its lack of toxicity and low cost of manufacture compared to proprietary biologics, VIP may be uniquely attractive to those focused on global countermeasures against COVID-19, says the company.
.
.
.
"With the conclusion of the analysis of primary and secondary endpoints, we are able to focus on prespecified endpoints that confirm the mechanism of action," stated Prof Jonathan Javitt, M.D., MPH, Chairman and CEO of NRx, on August 30, 2021. "This latest analysis provides confirmatory evidence that aviptadil improves the lung's ability to transmit oxygen within a day of initiating treatment. The benefit was seen across all patients, all baseline severities, and all types of hospitals. We believe this new finding illustrates ZYESAMI's mechanism of action in a placebo-controlled trial and supports our application for Breakthrough Therapy Designation to the U.S. FDA."
https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic
I am expecting Dr. J to agree to every Relief Therapeutics demand. Because if JJ holds back, he will lose his company and 3/4's of a billion bucks in income.
this will be settled out of court.
~ Fred, Y@h00 RLFTF finance conversations
————————>
Interesting proclamations from the recently FDA meetings....
Evidently they feel they have great "Agility and they will also Revoke" any drug with a EUA if it becomes apparent that it is not as effective in this ever changing Covid 19 virus pandemic, now redefined in UK & EU as ENDEMIC....
So i wonder how much longer we will see GILEAD Resmedivir as having its EUA and stay as part of the SOC....???
https://m.theepochtimes.com/mkt_breakingnews/remdesivir-reduced-risk-of-hospitalization-when-given-to-covid-19-patients-early-study_4010494.html?utm_source=newsnoe&utm_medium=email&utm_campaign=breaking-2021-09-22-1&mktids=290d33cbb516cfa629b7303525a695de&est=uYayh%2BscHQJjBmCgQnvaNIRvbC76xI5lvY6G9TSMiRQvkvMUn9AlGBN%2FHLpk6e7L5IozjAIC
DON'T hold your breath...
No doubt that ZYESAMI (AVIPTADIL RLF-100) tm should be approved for EUA and be used as SOC...
GLTA LONGS....
~ Gorgeous, Y@h00 RLFTF finance conversations
I just reposted “OU” Y@h00 post. He is leaning in favor of EUA approval. I am of the opinion that Aviptadil is safer if not more effective than vaccines, antivirals and other therapeutics for COVID-19.
———>
Zyesami (Aviptadil) is a formulation of synthetic human Vasoactive Intestinal Peptide (VIP), which was first discovered in 1970. NRx was the first to formulate aviptadil for human intravenous and inhaled use under the "Good Manufacturing Practices" standards in 2020.
VIP is known to target the VPAC1 receptor of the alveolar type II (ATII) cell and protect that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents. In addition, VIP prevents apoptosis, blocks cytokines, lowers TNFa levels, reverses CD4/CD8 ratio, and reduces cough and dyspnea in nonclinical and clinical studies.
Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and primarily concentrated in the lungs. In addition, VIP has been shown in more than hundreds of peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation says the company.
https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic
WHY WOULD THE FDA WITHHOLD EUA APPROVAL OF ZYESAMI (TM)???
On Wednesday, the United Kingdom became the first country to clear the Pfizer vaccine. Over the past week, FDA Commissioner Stephen Hahn has been called to the White House twice to explain why the vaccine could not be authorized more quickly. Those urging speed point to the two-dose vaccine’s incredibly strong short-term efficacy — it prevents 95% of symptomatic Covid-19 cases, at least based on a few months’ data — and that it appears safe overall.
With more than 2,000 Americans dying from Covid-19 daily, they argue, what was the risk of trying it sooner?
The FDA has said in multiple public forums that it could not have moved any faster. The agency’s staff “were eating turkey sandwiches on Thanksgiving while reviewing documents,” Peter Marks, who heads the FDA center conducting the vaccine reviews, said on a Thursday webcast run by the Journal of the American Medical Association.
https://www.statnews.com/2020/12/04/how-key-decisions-slowed-fdas-review-of-covid-19-vaccine-but-also-gave-it-important-data/
CAN THE BEST OF VACCINES, ANTIVIRALS, THERAPEUTICS DO WHAT SAFE AND EFFECTIVE ZYESAMI (TM) (AVIPTADIL) CAN DO??? PHARMACISTS CAN WALK AND ATTORNEYS CHEW!!!
Zyesami (Aviptadil) is a formulation of synthetic human Vasoactive Intestinal Peptide (VIP), which was first discovered in 1970. NRx was the first to formulate aviptadil for human intravenous and inhaled use under the "Good Manufacturing Practices" standards in 2020.
VIP is known to target the VPAC1 receptor of the alveolar type II (ATII) cell and protect that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents. In addition, VIP prevents apoptosis, blocks cytokines, lowers TNFa levels, reverses CD4/CD8 ratio, and reduces cough and dyspnea in nonclinical and clinical studies.
Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and primarily concentrated in the lungs. In addition, VIP has been shown in more than hundreds of peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation says the company.
https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic
I don’t know how many he wants and needs but it seems that just like influenza, highly infectious COVID-19 is here to stay.
The FDA (CDC, NIH, NIAID) needs to make a decision.
https://www.mayoclinic.org/coronavirus-covid-19/map/new-jersey
Past flu seasons have followed no pattern. A mild one is sometimes followed by a severe one, sometimes by another mild one, and vice versa.
“It’s hard to say what the impact of a very, very low influenza season is,” Ann Moen, MPA, chief of influenza preparedness and response at the WHO, said in an interview. “If it continues like this, it wouldn’t be unreasonable to think that you’re going to have a more severe season.”
The reason? “I think some locations that have fully reopened will be vulnerable to large flu seasons because of the loss of population immunity in the past 18 months,” Cowling said.
https://jamanetwork.com/journals/jama/fullarticle/2783644
The imaging findings of COVID-19 pneumonia mimic influenza, SARS-CoV, and MERS-CoV pneumonia [18]. Cevik et al. [26] performed a study about SARS-CoV-2's, SARS-CoV-1's, and MERS-CoV’s viral load dynamics, duration of viral shedding, and infectiousness.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8308954/
If the allegations are true, RLF is playing the long game in kicking NRXT out of the collaboration. Lawsuit #1, ensuring they get access to everything they need. They're essentially getting a court to order to force NRXP to give access to their books...If RLF gets access to everything and can then prove misallocation of funds, they're going to have every piece of evidence needed for a second lawsuit to end the collaboration agreement and have court ordered restrictions put on NRXP
~ Chris, Y@h00 RLFTF finance conversations
CORRUPT???
“According to the allegations in today’s complaint, Regeneron funneled tens of millions of dollars in kickbacks through a third-party foundation to ensure that few Medicare patients paid a co-pay on Eylea and that physicians who prescribed and purchased the drug did not have to collect Medicare co-pays from their patients,” said United States Attorney Andrew E. Lelling.
“Regeneron allegedly paid these substantial sums only after confirming that the foundation needed the money to cover co-pays only for Eylea, and not for competing drugs, and that the company’s payments would generate a handsome return on investment, or ‘ROI,’ in the form of Medicare payments for Eylea. Furthermore, senior company executives allegedly took extensive measures to cover up the scheme.”
https://www.justice.gov/usao-ma/pr/united-states-files-suit-against-drug-manufacturer-regeneron-paying-kickbacks-through-co
Does a private placement agent conduct a formal and thorough examination prior to granting approval or clearance???
https://www.streetinsider.com/dr/news.php?id=18840649
There is a simple solution. The Board of Directors of NRXP assuming the allegations are true against Dr. Javitt need to fire him. They have a responsibility to the shareholders a moral obligation to future patients and their own integrity to protect. People are acting as if this is a private company and Dr. Javitt owns it. No, simply fire him and move on.
~ Bruce, Y@h00 RLFTF finance conversations
For instance, Dr. Javitt never voluntarily disclosed to Relief the fact that an Emergency Use Authorization for aviptadil had been denied by the FDA in November 2020 – an intentional omission that caused Relief to not be able to report this obviously material information for over a month. This behavior not only compromises Relief’s ability to advance development of the drug in territories worldwide but also puts Relief at regulatory risk due to an inability to fulfill its disclosure requirements as a publicly traded company (page 6)
https://www.dropbox.com/s/zmnr3ynegprpz97/not_assigned_relief_therapeutics_ho_v_relief_therapeutics_ho_complaint_2%20%281%29.pdf?dl=0
FUNCTION OF PATENT ATTORNEY: DEFENSE AGAINST PATENT INVALIDATION OR ROBBERY
To better understand the use of external controls to support product development and approval, we reviewed FDA regulatory approval decisions between 2000 and 2019 for drug and biologic products to identify pivotal studies that leveraged external controls, with a focus on select therapeutic areas. Forty-five approvals were identified where FDA accepted external control data in their benefit/risk assessment; they did so for many reasons including the rare nature of the disease, ethical concerns regarding use of a placebo or no-treatment arm, the seriousness of the condition, and the high unmet medical need. Retrospective natural history data, including retrospective reviews of patient records, was the most common source of external control (44%). Other types of external control were baseline control (33%); published data (11%); and data from a previous clinical study (11%). To gain further insights, a comprehensive evaluation of selected approvals utilizing different types of external control is provided to highlight the variety of approaches used by sponsors and the challenges encountered in supporting product development and FDA decision making; particularly, the value and use of retrospective natural history in the development of products for rare diseases.
https://link.springer.com/article/10.1007/s43441-021-00302-y
"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."
60/40 (US, Canada, Brazil, Turkey, Japan) and 85/15 EU/ROW :
https://relieftherapeutics.com/partnering
Money. Money everywhere.
~ Franz, Y@h00 RLFTF finance conversations
—————————————
@PJ you have no clue about FDA procedures.
This acceptance is very relevant !
AND WHY ARE YOU TALKING OF FILLINGS ? DO YOU NEED A DENTIST ?
It is F I L I N G like file ! Ok ?
~ IG, Y@h00 RLFTF finance conversations
I tell you from my side why the acceptance for filing is in my eyes so relevant.
I was doubting after all the stories of Dr. J and Dr. Ram that RELIEF is ready to perform a filing act on their own ! The process of EUA/NDA of Zyesami has been so much driven by JJ - I was somewhat getting this impression. (Sorry RLF, I still love you).
Now today seeing RLF to perform a successful FDA filing is very relevant since you see that this company is able to perform this very demanding procedure.
An accepted file for NDA needs many details, starts with preclinical data, toxicology in mice, GMP production details, goes to package insert writing (very relevant) to human phase III data presentation, labeling, supply chain and a postmarketing plan etc.
Now I see that RLF is very capable, even better FDA proven to be capable, to perform such an act.
This is very reassuring and shows to me that RLF can act on its own as independent pharma company !
They have everything in place to advance to Big Pharma!
~ IG, Y@h00 RLFTF finance conversations
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3665228
Check out the “NOTE” section.
Courtesy of Mav on ST.
~ Hoid, Y@h00 RLFTF finance conversations
ACER THERAPEUTICS AND RELIEF THERAPEUTICS ANNOUNCE FDA ACCEPTANCE FOR FILING OF NEW DRUG APPLICATION FOR ACER-001 TO TREAT UREA CYCLE DISORDERS
https://relieftherapeutics.com/newsblog/acer-therapeutics-and-relief-therapeutics-announce-fda-acceptance-for-filing-of-new-drug-application-for-acer-001-to-treat-urea-cycle-disorders
~ Franz, Y@h00 RLFTF finance conversations
From Dr Joey on Facebook!!
Attention:
Black Rock, Herculis Partners, Vanguard, State Street, Credit Suisse, UBS, GEM, Nuveen, DWS Intl...and now, the lovely State of Florida's Teacher Retirement and Government Pension Plan (known collectively as, the "Florida State Board of Administration") is the newest honoree to be named to the 700k -1M+ club for RLFTF Institutional Investors!!! That's right, if you have a state retirement plan, teacher retirement plan, or pension plan in FL, congrats to you because your pension will soon be much more sunny to look at ;) . This was part of a private placement earlier this year I believe, but I was just now able to confirm it.
And, who was that saying we don't have investment funds, hedge funds, and big banks invested in us!?! I thought I saw that somewhere ?? ??!?! Anyway, UBS, Credit Suisse, And Vanguard beg to differ! Not to mention all the others listed above! I just wanted to share that with you because I am waiting for one last phone call this week before releasing the video. But trust me, this video will be worth it, and if all goes according to plans, you will be surprised with what's to come! GLTA!
~ Bigdog, Y@h00 RLFTF finance conversations
WAY FORWARD FOR AVIPTADIL???
Accelerated assessment reduces the timeframe for the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) to review a marketing-authorisation application. Applications may be eligible for accelerated assessment if the CHMP decides the product is of major interest for public health and therapeutic innovation.
Evaluating a marketing-authorisation application under the centralised procedure can take up to 210 days, not counting clock stops when applicants have to provide additional information. On request, the CHMP can reduce the timeframe to 150 days if the applicant provides sufficient justification for an accelerated assessment.
https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/accelerated-assessment
DOES RLFTF HAVE ENOUGH TIME TO REALIZE/MAXIMIZE THE PROMISES OF AVIPTADIL BEFORE THE PATENT EXPIRES???
2006-03-07…Application filed by MondoBiotech AG
2008-07-03…Publication of US20080161237A1
2012-05-15…Publication of US8178489B2
2012-05-15…Application granted
Status
Active - Reinstated
2029-07-03…Adjusted expiration
https://patents.google.com/patent/US8178489B2/en
The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) concur more than 90% of the time in their decisions to approve new drugs, according to a new study from EMA and FDA officials that looked at 107 applications from 2014 to 2016.
In just eight of the 107 applications, FDA initially declined to approve a new drug or biologic while EMA approved it, although in all eight of those cases, FDA ended up approving that drug or biologic. And in one case (Takeda’s Ninlaro (ixazomib) for multiple myeloma), FDA approved the treatment and EMA initially did not, but later did.
“Overall, taking account of the resubmitted and reexamined applications, the EMA and the FDA had final discordant marketing authorization decisions for two drugs: corifollitropin alfa and ataluren,” the study notes, as both were approved by EMA and not FDA. ~ RAPS
LONG LIVE Zyesami (TM) ~ Aviptadil ~ RLF-100…Shukransaid???
While such endpoints may get drugs to the market more quickly, they must still meet the same standards for safety and efficacy as their traditionally approved counterparts (substantial evidence based on adequate and well-controlled clinical investigations). The difference is that drugs granted accelerated approval must promptly conduct post-marketing confirmatory trials to verify the clinical benefit (as early as underway at the time the marketing application is submitted).[11]
Sponsors considering accelerated approval should discuss their drug development program with the reviewing division at the earliest stages of development. Among other concerns, accelerated approval will necessarily dictate a more rapid pace for other aspects of the development program such as CMC [Chemistry, Manufacturing & Control] or development of necessary companion diagnostics.[12]
https://pharmdevgroup.com/fda-expedited-programs-explained/
SIX INDICATIONS WITH TWO BIOMARKERS???
In the coming year, we intend to initiate clinical trials for the following indications:
1- COVID “longhauler” syndrome: millions of Americans continue to suffer from reduced respiratory capacity and require home oxygen in order to maintain adequate blood oxygen levels.
2- Sarcoidosis: this chronic lung disease affects 185,000 Americans and causes pulmonary disability and death in 1% to 5% of those affected. The FDA has recognized Sarcoidosis as an orphan disease.
3- Acute Respiratory Distress Syndrome (ARDS): this is the condition that Prof. Sami Said first treated in the last years of his career, together with our Principal Investigator, Dr. J. Georges Youssef of Houston Methodist Hospital. Seven of the 8 patients they treated at Stonybrook University Hospital survived the Intensive Care Unit and 6 successfully left the hospital.
4- Checkpoint inhibitor pneumonitis: one of the most promising developments in cancer chemotherapy is the advent of checkpoint inhibitor drugs, of which Keytruda® (pembrolizumab) is the best-known example. While these drugs have shown promise in previously hopeless malignancies, they cause a highly unpleasant lung inflammation (pneumonitis) that is a challenge for patients and their families. There are reports in the medical literature of substantial relief being achieved with inhaled aviptadil.
5- Preservation of donor lungs both before and after transplant: There is a substantial pre-clinical literature on the effect of aviptadil in protecting donor lungs both while outside the body and after transplant. Dr. Youssef has treated some lung transplant patients under an investigator-sponsored IND with encouraging results.
6- Chronic Obstructive Pulmonary Disease (COPD): Highly provocative data have been shared with us regarding the potential for aviptadil to improve symptoms in patients with advanced COPD. More than 15 million Americans suffer from COPD and treatment at this time is largely confined to custom-compounded off-label use of inhaled steroids and bronchodilators. Our manufacturing partner, Nephron Pharmaceuticals, is one of the nation’s largest suppliers of custom inhaled medicines.
Thus, we have lots of work to do and many millions of patients who may require ZYESAMI. We are working with Mannkind (Nasdaq:MNKD) to adapt their dry powder insulin delivery system to deliver inhaled aviptadil in order to achieve a room-temperature stable, convenient to use medicine. We are also working with TFF Pharmaceuticals (Nasdaq:TFFP) to develop a long-term stable reconstitutable form of ZYESAMI.
Investors ask us on a daily basis when the FDA will grant EUA to ZYESAMI for the treatment of Critical COVID-19. As you know, the FDA wrote to us in December 2020 and advised that they required randomized prospective data to consider granting EUA. Dr. Peter Stein of the FDA stated that the FDA remained committed to working with us on our investigational medicine and advised us that the FDA would review any submission of randomized prospective data “promptly.” Although there is no statutorily mandated period within which the FDA must make a determination on EUA, the project manager who is supervising our EUA application advised us on Friday, October 1, that the review is ongoing and that the FDA is awaiting input from some members of its staff.
In the course of developing randomized prospective data in support of the EUA, we believe that we have fulfilled the requirements for Breakthrough Therapy Designation and have submitted that application to the FDA. We may also meet the legal requirements for accelerated approval under section 506c of the Food, Drug, and Cosmetics Act, based upon the findings in two separate trials demonstrating a statistically-significant response on two biomarkers: Respiratory Distress Ratio and Cytokine IL-6.
The statute states that the FDA may grant accelerated approval to:
. . . a product for a serious or life-threatening disease or condition . . . upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.
As you know, ZYESAMI is one of three products in our pipeline with potential for approval in 2022, the other two being NRX-101 and the BriLife vaccine. Each product has the potential to save countless lives and to generate significant value for shareholders. We will provide updates about BriLife and NRX-101 in future communications.
On behalf of the entire NRx team, we thank you for placing your trust in us as we work tirelessly to improve patients’ health and save lives. We look forward to sharing further results in the coming months.
Best Regards,
Jonathan C. Javitt, MD, MPH
Chairman and CEO of NRx Pharmaceuticals
Cautionary Note Regarding Forward-Looking Statements
This statement of NRx Pharmaceuticals, Inc. includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company’s strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company’s management. The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.
WHAT IS ACCELERATED APPROVAL PATHWAY???
The United States Food and Drug Administration (FDA) initiated the FDA Accelerated Approval Program in 1992 to allow faster approval of drugs for serious conditions that fill an unmet medical need. ... If the drug later proves unable to demonstrate clinical benefit to patients, the FDA may withdraw approval. ~ Wiki
WHAT IS THE BIGGEST DIFFERENCE BETWEEN STANDARD APPROVAL OF A NEW DRUG APPLICATION AND ACCELERATED APPROVAL???
The difference is that drugs granted accelerated approval must promptly conduct post-marketing confirmatory trials to verify the clinical benefit (as early as underway at the time the marketing application is submitted…Pharmaceutical Development Group
WHAT ARE ACCELERATED CLINICAL TRIALS???
Introduced in 1992 and modified in 2012, accelerated approval allows the FDA to base approval of drugs for “serious conditions that fill an unmet medical need on whether the drug has an effect on a surrogate or an intermediate clinical endpoint.” In other words, marketing approval can be based on clinical trials that do not yet show an improvement of a definitive endpoint such as increased longevity, reduction in the incidence of heart attacks or healing of an infection.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6690300/
WHEN CAN YOU ASK FOR ACCELERATED APPROVAL???
Accelerated approval is used when a disease course is long and measuring the clinical benefit would require significant time.
https://www.definitivehc.com/resources/glossary/accelerated-approval
Sorry to disappoint, but this is not true.
This is merely a recalculation of the shares that could be bought (on Reliefs request) under the SSF with the current SP. It was based on .016 CHF, the amount of shares would be even higher today...
Just check the link:
"Change in the information subject to the obligation to notify"
"Pursuant to a Share Subscription Facility agreement (SSF), GEM committed to provide up to CHF 50 million to RELIEF
THERAPEUTICS Holding SA in exchange for registered shares of RELIEF THERAPEUTICS Holding SA in the period from January 20, 2021, to January 20, 2024, at the discretion of RELIEF THERAPEUTICS Holding SA, subject to certain exceptions and limitations. No drawdowns have been made until September 1, 2021,resulting in a remaining balance of the full amount under the SSF of CHF 50 million. GEM's purchase position has been calculated using the closing price of the registered shares of RELIEF THERAPEUTICS Holding SA on SIX Swiss Exchange on September 1, 2021 (CHF 0.178) and applying the 10% discount agreed in the SSF (resulting in a share price of CHF 0.1602), by dividing the
remaining balance under the SSF of CHF 50 million by such share price of CHF 0.1602............ "
~Grid, Y@h00 RLFTF finance conversations
According to this link GEM (our main shareholder) bought once again 1'158'000'000 pieces of the stock.
Furthermore, they never sold a share during this painful down period.
https://www.ser-ag.com/en/resources/notifications-market-participants/significant-shareholders.html#/shareholder-details/TAL9700026
~ Rafael, Y@h00 RLFTF finance conversations
Joe K, I hope you found this one interesting as well. I know I did!
Was looking at the Activ-3b primary EP and it looks very favorable for us.
The primary ep for NRx trial was very difficult to hit even if the issues with regional hospitals didn’t happen. It was a binary ep of recovery of respiratory failure followed by mortality (another binary event) although they where able to change to odds of survival. Neither in our favor.
We know Aviptadil had a 10 day LOS reduction across all patients and sites. Highly Statistically significant. That is basically what the NIH end point is with more definition which imo will help even more.
Recovery, assessed at 90 days [ Time Frame: Thru Day 90 ]
Recovery categorized as 1 (Best): At home and not receiving new supplemental oxygen for ≥ 77 consecutive days; 2: At home and not receiving new supplemental oxygen for 49-76 consecutive days; 3: At home and not receiving new supplemental oxygen for 1-48 consecutive days; 4: Discharged from hospital but either not yet home or home but receiving new supplemental oxygen; 5: Still hospitalized or receiving hospice care; 6 (Worst): Dead.
So this fits perfectly into Aviptadil hands for great success. The patients who get better will get better faster. This EP should show high stat significance with an exceptionally run trial.
I know we all want the EUA but the results from this study are 6 short months away! These results will change the course in pulmonary medicine imo. It will be peer reviewed and published immediately. If the FDA screws around and throws out a denial it could be the greatest opportunity for cheap shares you could ever find. I know it would suck and I hope it doesn’t happen but I do believe 2022 will be a massive year regardless.
Also keep in mind Javitt is trying to get a bio marker approval for IL6 reduction. This program allows for a streamlined approach to multiple development programs with the same drug. So if approved they don’t need new endpoints for other indications. They just prove IL6 reduction which is huge. Here is a study on COPD that shows the effect of IL6 with people with COPD.
https://www.sciencedirect.com/science/article/pii/S0954611103002671
~ Kpags, Y@h00 RLFTF finance conversations
VIP, the magic wand
Was looking at the Activ-3b primary EP and it looks very favorable for us.
The primary ep for NRx trial was very difficult to hit even if the issues with regional hospitals didn’t happen. It was a binary ep of recovery of respiratory failure followed by mortality (another binary event) although they where able to change to odds of survival. Neither in our favor.
We know Aviptadil had a 10 day LOS reduction across all patients and sites. Highly Statistically significant. That is basically what the NIH end point is with more definition which imo will help even more.
Recovery, assessed at 90 days [ Time Frame: Thru Day 90 ]
Recovery categorized as 1 (Best): At home and not receiving new supplemental oxygen for ≥ 77 consecutive days; 2: At home and not receiving new supplemental oxygen for 49-76 consecutive days; 3: At home and not receiving new supplemental oxygen for 1-48 consecutive days; 4: Discharged from hospital but either not yet home or home but receiving new supplemental oxygen; 5: Still hospitalized or receiving hospice care; 6 (Worst): Dead.
So this fits perfectly into Aviptadil hands for great success. The patients who get better will get better faster. This EP should show high stat significance with an exceptionally run trial.
I know we all want the EUA but the results from this study are 6 short months away! These results will change the course in pulmonary medicine imo. It will be peer reviewed and published immediately. If the FDA screws around and throws out a denial it could be the greatest opportunity for cheap shares you could ever find. I know it would suck and I hope it doesn’t happen but I do believe 2022 will be a massive year regardless.
Also keep in mind Javitt is trying to get a bio marker approval for IL6 reduction. This program allows for a streamlined approach to multiple development programs with the same drug. So if approved they don’t need new endpoints for other indications. They just prove IL6 reduction which is huge. Here is a study on COPD that shows the effect of IL6 with people with COPD.
https://www.sciencedirect.com/science/article/pii/S0954611103002671
~ Kpags, Y@h00 RLFTF finance conversations
No, several posts of KingJake319 have been deleted from $t0cwit$ including the one I copied into my post. Other posts you can read here.
https://stocktwits.com/KingJake319
That I don’t have any information on.
11:10 – 11:40 | PUBLIC-PRIVATE PARTNERSHIPS
PJ Brooks, Program Director, Rare Diseases, NIH; Jonathan Javitt, CEO, NRx; Bill Mezzanotte, EVP, Head R&D & CMO, CSL Behring; Iskra Reic, EVP, Europe & Canada, AstraZeneca; Courtney Silverthorn, AVP, Research Partnerships, Foundation for the NIH
Moderator: Art Krieg, CSO, Checkmate Pharmaceuticals