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COVID-19 is about ARDS
GENEVA, SWITZERLAND / ACCESSWIRE / September 2, 2021 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that its recently acquired German subsidiary, AdVita Lifescience GmbH ("AdVita"), has received regulatory clearance to commence a phase 2 clinical trial in Germany to evaluate inhaled aviptadil for the treatment of sarcoidosis.
Following a proof-of-concept trial in 20 sarcoidosis patients which demonstrated the suppression of inflammatory mechanisms of the lung in combination with amelioration of dry cough and exertional dyspnea, AdVita received clearance by the German medical regulatory authority Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) to conduct a randomized, double-blind, multicenter clinical trial in sarcoidosis patients.
https://finance.yahoo.com/news/relief-reports-regulatory-clearance-germany-053000439.html
PW, my limited vision/perception tells me ADR and SARCOIDOSIS/ARDS are on the front burners. If EUA happens by February 2022 that would be great but I don’t think RLFT.F is counting on that anyway.
https://www.fidelity.com/learning-center/investment-products/stocks/understanding-american-depositary-receipts
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6323477/
https://relieftherapeutics.com/newsblog/relief-therapeutics-holding-sa-six-rlf-and-neurorx-inc-file-fda-ind-for-aviptadil-to-treat-covid-19-induced-respiratory-distress
Regardless of what the share price does, it does not change the total addressable market and potential market cap to be split between Rlf and Nrxp according to whatever collaboration amendment to be made. When EUA is granted, share prices for both companies will shoot up to where one would have expected last year when they first invested. Timeline has changed, goal post has moved, but the scoring points for a touch down does not change. Buying down is your best investment strategy.
~ Andy, Y@h00 RLFTF finance conversations
Remember when .48 seemed like a great dip buy and we where all jealous of .05 club? Major ooof
~ Kpags, Y@h00 RLFTF finance conversations
Kpags2 hours ago
@Big obviously you couldn’t answer my simple question? 70% of the study had a 22% reduction in mortality. Hard to believe that is just statistical chance? Further data will prove this out but it doesn’t need to since NIH EP is well designed and Taylor made for Aviptadil impact.
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FC
FC7 hours ago
@Kpags the correlation between these and the biomarkers will be even more interesting. No chance for just chance Let's find out more next week.
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Kpags
Kpags8 hours ago
@Big I am not an idiot. Raw data 70% of the study had a 22% decrease in Mortality at day 60? Explain that Please? Was that chance? Please give me your honest answer
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FC
FC9 hours ago
@Big the more you talk, the leakier you are Remember, numbers don't lie.
Now let me prove why you are a fake. You said you treated 22 EAP patients in your hospitals. Fine. Do you know how many total EAP patients NeuroRx has granted? By the time they reported 60days trial data, the number of EAP was 240 (196 of these received maximal intensive care, the rest went to palliative care). So congratulations according to you, you happened to treat 10% of the total EAP. The direct consequences are:
1. This made your hospital on the top of the EAP hospital list. So 5% can be easily verified with NeuroRx. Also what made NeuroRx stick with such a low competence hospital for EAP? Keep in mind the overall survival rate for EAP in maximum care setting was 65%.
2. Your 5% propelled the rest of EAP program's survival rate to 72% - this figure is higher than the Aviptadil arm in the RCT trial. Your faking number is creating a dilemma that you can't argue away.
You are no doctor. Now stop your all nonsense and be a decent human for once.
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Big
Big9 hours ago
@FC we had 1 patient survive at the 28 day mark out of 22 treated. All extremely ill. Not exactly 5% but close enough. The one "survivor" eventually died.
I'm board certified in infectious diseases and critical care--I spent years at the NIAID. And, as I've been saying all along, I'm writing a paper on how companies spin data to deceive enthusiatic but uneducated investors.
FC-- use common sense--if adviptadil reversed SARS-CoV-2 lung damage as touted by the developers, why aren't smart docs beating the doors down to get it to treat their dying patients?? It's because smart docs can read an article that was published in the pay-to-publish Journal of Infectious Diseases and Treatment and immediately see the enormous flaws in the study design, execution, and analysis. The average layperson sees a stock price of 0.40 and a p < 0.00001 and gets an erection (all for all the wrong reasons).
You're probably too young to know this, but years ago VIP was the miraculous answer to ARDS. That didn't pan out ...
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FC
FC10 hours ago
@Big all right. There is no need to waste more time with you. You think giving me a very low number would help with your argument. You have no idea how statistics work. You can't even fake properly lol
Physicians are heroes of this pandemic. Please for sake of you and your family stop being an imposter.
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Big
Big10 hours ago
@FC about 5% at 4 weeks.
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FC
FC10 hours ago
@Big what was the survival rate for your EAP patients? I just need this piece of data from you.
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Big
Big10 hours ago
@FC wow..again, wow...what part don't you believe? My credentials? I did my MD PhD at Columbia. Or my analysis. I'm not a troll. I'm trying to understand how apparently educated and sophisticated investors can be strung along for so long and continue to have faith in results that should not require faith. Why do you believe that adviptadil "works". You understand the p value you cited was a result of a manipulated analysis (for example, the p02 value reported for the adviptadil group was the admission value and not the value when the patient received the drug--big mistake)
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FC
FC10 hours ago
@Big you claimed you have used Aviptadil under EAP. I am not gonna ask which hospital you work for. Please just show me one piece of data. What was the survival rate for your EAP patients?
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FC
FC10 hours ago
Haven't seen so many trolls in my thread lately. Yeah, MD, PhD, my #$%$, you Big liar can't even pass the high school reading comprehension test. And look he is talking about trial design blah blah.
@GeraldS dude you are super annoying. If you can't understand TH, RCT, DSMB, why are you even here investing?
All the numbers in my post were from the phase 2b/3 RCT trial except the 81% survival rate which was for the 21EAP study. They have clearly shown Aviptadil at least achieved clinical significance in the trial.
There is another piece of data that you might find interesting. There were 36 MV patients enrolled. The survival rate at 60days were: 58.6% (A) : 0 (P). The p value was 0.001. Clinical trials are always full of surprise.
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Mark
Mark11 hours ago
I just let NIH 3b clinical trials play out. No rush https://www.nih.gov/research-training/medical-research-initiatives/activ/covid-19-therapeutics-prioritized-testing-clinical-trials
Bullish
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Big
Big11 hours ago
@Mark did you read the Journal of Infectious Diseases and Treatment article? It was horrendous--they even mislabeled the exclusion criteria as inclusion criteria. As a fellow physician, what makes you believe this drug has efficacy? Very curious.
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Mark
Mark11 hours ago
@GeraldS Hello, Gerald. Yes, I am a medical professional and I do respect research currently being done at NIH. 3b clinical trials is still being conducted and we will get more updates next summer.
I am invested for long term and I do not get too excited about temporary gyrations in the stock market.
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Bullish
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Richard
Richard11 hours ago
@GeraldS
I think there isn’t much money left !
They have asked for
Or received government
Monies for the Studies
It is costly to run and operation like this
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GeraldS
GeraldS12 hours ago
@Mark Without a double blind clinical trial how can you make such a statement? Your just keeping us holding on to false hope. The only way we're going to recoup our money now is a law suit.
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GeraldS
GeraldS12 hours ago
@Mark What are your qualifications to guarantee the ultimate success of Zyesami? Are you a wishful thinker, or a shill, and accomplice to the gang pushing an ineffective treatment. Who are you? Sadly, people can come on this discussion site in total anonymity. I suppose it's a double edge sword, but it does open us to being swindled.
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Big
Big12 hours ago
@GeraldS 100% agree.
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Big
Big12 hours ago
@Mark...if adviptadil was such a "game changer" as you say, demonstrating its efficacy would have been easy. There have been two failed EUA applications. I'd reflect on those facts before encouraging folks to invest.
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GeraldS
GeraldS12 hours ago
@Big What are these unethical companies going to do with the millions of dollars we've invested in them? Live the high life like the super rich? Is that their point? Or do they have other projects they want to finance that are legitimate? It's beginning to look like legal theft. The intitial trials were enough to show it didn't work, and they're just stringing us along. I wish the FDA would be more transparent and clamp down on companies who are intentionally stealing from investors.
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GeraldS
GeraldS12 hours ago
@wax The patience story is why he are still here losing our pants, socks, and underwear when we could have walked out after losing just our coat and tie!
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Mark
Mark12 hours ago
Unfortunately most laymen wouldn’t notice the difference between antivirals from antibacterial medications.
Pfizer and MERK drugs only targeting patients suffering from viruses but not bacterial infections. Millions of more people suffer from Bacterial then viruses infections.
Amazingly. ZYESAMI drug helps patients from viruses, bacterial and other pulmonary complications.
Even long after Covid viruses are eradicated, ZYESAMI drug will be forever needed and long term investors will all become millionaires.
We have many medical professionals on this forum. I would like your input.
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Mark
Mark12 hours ago
Many investors seems to be confused about FDA EUA. FDA never rejected ZYESAMI potential but it wants more then few dozens trials before they will approve the drug.
Dr. Fauci and many others know the potential of ZYESAMI is game changer.
Both Pfizer and MERK drugs are antiviral drugs. It only targets patients suffering from respiratory complications related to viruses but not bacterial infections.
ZYESAMI drug is comprehensive drug for viruses, bacterial and other pulmonary complications. It’s miraculous drug and not just antivirals
Ike Pfizer or MERK.
FDA will soon or later must approve ZYESAMI. NIH is still enrolling and conducting 3b clinical trials. I guarantee ZYESAMI will make make investors millionaires
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Big
Big13 hours ago
@GeraldS you are 100% correct. I wish folks would stop throwing their money away. Based on the data we've seen, there's not one credible and objective (i.e. not holding stock) academic physician who thinks adviptadil improves severe COVID-19 respiratory failure. No one, of course including me. Yet folks are throwing more cash at a .06 stock??? Why??
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Big
Big14 hours ago
Potent not patent lol
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Big
Big14 hours ago
I don't know where to start. Powering a study (basically, how many patients to enroll) is a statistical procedure based on mutilple estimates/assumptions (most important how much of an impact the drug under study will have on the primary endpoint). It isn't "just enroll a few more patients and we'll see what happens". In GENERAL, the more patients you need to see a significant difference between groups, the weaker the effect of the agent being studied. For example, if a blood pressure medication truly dropped your systolic pressure by 3 points (very small benefit), you may have to power your study to enroll a million people to tease out such a tiny benefit. If the med was more patent and dropped your pressure by 20 points, you may only have to enroll couple hundred subjects. The point is sample size must be pre-planned during study design.
If adviptadil "worked" and had "clinical significance" the FDA would have granted the EUA. There is no conspiracy. The analysis published in the Journal of Infectious Diseases and Treatment "article" is not sound science. The article is littered with basic "mistakes"-- mislabeled scans, wrong table titles...again, the FDA re-analyzed the data correctly and found no benefit--I truly wished the med did what the company claims it does, but it didn't. This is why I'm here--writing a paper on how unethical biotech companies can spin data so investors give them money
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GeraldS
GeraldS14 hours ago
I'm sorry, but you're just beating a dead horse. Why do we do blinded studies? When you do a blinded study you can't fake the results. For all we know they chose 'controls' that were less likely to survive, either intentionally, or subconsciously. We just have no way of knowing. The blinded study so far showed no positive results whatsoever based on the agreed end point, survival at 28 days. Doctor Javitts went back and cherry picked the data after the unblinding to find 'significance'. That's just not done... Period. And that my friends is the story so far. I so wish it were not true. You folks think I'm bashing? No, I'm the one who'se bashed, along with the majority on this site....the believers. Also, we do not know the results of the later blinded study on which the FDA made its decision. If anyone does, I and the rest of us dearly want to see it. 131 patients is more than enough to show "may be effective" as a criteria.
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GeraldS
GeraldS14 hours ago
What is TH? test hospital? You didn't bother to define it. RCT Random Control...T? DSMB? Why can't you spell it out then use initials in paranthesis, to save time of me guessing or trying look up and elimination? Very annoying. Also, where did you get these numbers, as I have not been able to find them. It drives me #$%$ when I try to read this stuff. You ought to learn standard protocol for write ups. You could start by Googling it, or even reading a report from New England Journal of Medicine, or Nature, to see how professionals do it.
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12345
1234518 hours ago
@FC you are correct my mistake it was not the open label it was the phase 2/3 fast track
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FC
FC19 hours ago
@wax right we certainly need patience here. Don't bank on NIH to turn up something before the trial completes. A 3 standard deviation on all-cause mortality advantage is a very high bar. The accelerated approval pathway might have a merit here. Let's see what they come up with in next week's conference call.
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wax
wax19 hours ago
@FC ... taking into consideration Aviptadil is a synthesized peptide found in every creature walking the planet that breathes air, whether it works or not isn't the question. The question is how WELL does it work ... how effective is it ??
Does it do enough to justify EUA for covid ??
First ... shame on the FDA for approving all of these man made chemicals with a list of side effects longer than my arm and ignoring a natural peptide.
Second ... ACTIV-3b trial is coming up on the half way point of registration so, we may see something other than safety data sooner than later.
We just have to be a little more patient.
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Kpags
Kpags19 hours ago
@FC I think FDA has to approve accelerated approval then they can use the bio marker data. If the fda approves that and/or BTD that would go a long way.
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FC
FC20 hours ago
@12345 you said "also in that article the DSMB suggested based on those open label results that 144 is possibly sufficient to achieve stat."
Now let's look how the SeekingAlpha articles says:
"On July 16, 2020, Relief Therapeutics and NeuroRx announced that the Data Monitoring Committee conducted a planned review of the first 30 patients treated in the Phase II/III Fast Track trial (Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure (COVID-AIV)). Per the release:
The committee determined that the study appeared capable of reaching a statistically significant endpoint within its 144 patient sample size and voted for the study to continue until its next scheduled evaluation in four weeks."
I don't know where you got the idea DSMB based the recommendation on the open-label study - that's certainly NOT what SeekingAlpha was saying.
My post was copied from Y@h00 poster FC. If you can post there you may want to ask him. There is a more recent post from FC and that one got 41 replies. I will copy it over later in the morning or afternoon.
History of changes for study/clinical trial
https://clinicaltrials.gov/ct2/history/NCT04843761?A=1&B=28&C=Side-by-Side#StudyPageTop
AS THE WORLD TURNS, MORE EXPERIMENTAL VACCINE-SHEET HITS THE FAN
In Pfizer's FDA briefing document prepared for the Oct. 25 meeting was an admission that even according to the company's own unverified and misleading math, there is a scenario where there would be more hospitalizations among children for myocarditis — just one side effect — than from COVID. "Under Scenario 3 (lowest incidence), the model predicts more excess hospitalizations due to vaccine-related myocarditis/pericarditis compared to prevented hospitalizations due to COVID-19 in males and in both sexes combined," states Pfizer in page 33 of the document.
https://www.theblaze.com/op-ed/horowitz-fdas-own-pfizer-approval-document-suggests-myocarditis-from-shot-might-be-bigger-threat-than-covid
AS THE WORLD TURNS, MORE EXPERIMENTAL VACCINE-SHEET HITS THE FAN!!
https://www.jpost.com/breaking-news/covid-19-people-under-30-should-not-get-moderna-vaccine-france-684457
Yah00 took down my post last night. These are all factual numbers. I don't know on what base they removed it. I am reposting it as I notice some people are still arguing the effectiveness.
This was originally a comment to @12345 post. I am posting it as separated thread here and $NRXP to show that Aviptadil works.
The recently published open-label study took place in Houston Methodist under Dr. Youssef. It's made up of two groups: first group (treatment group) included the 21 patients who received Aviptadil under EAP, second group (control group) included 25 patients who were under standard care in the same ICU during the same timeframe as the 21EAP study was taking place. The treatment group had a 81% survival rate at 60days while the control group survived at only 21%. The EAP or open label group was not a problem. The problem of this study lies in the control group whose inclusion was kind of arbitrary (or maybe even hand picked). I complained last year on this board about this control group when they submit it for the first EUA. The conclusion of 9-fold survival advantage between these two groups was not science at all. The FDA came back requiring RCT result. RCT stands for Randomized Controlled Trial. The study can be either blinded or open label but the assignment to treatment arm and placebo (control) arm has to be randomized.
Now back to the 81% survival rate at 60days for the Aviptadil EAP. Is this data valid? Let me show you the survival rate at 60days for the THs:
TH1: 87.5% (A) 100% (P)
TH2: 70.6% (A) 40% (P)
TH3: 83.3% (A) 33.3% (P)
TH4: 84.6% (A) 75% (P) -> this one is Houston Methodist
TH5: 61.3% (A) 18.2% (P)
TH6: 100% (A) 50% (P)
TH Overall: 76% (A) 54% (P)
The RCT Aviptadil arm from Houston Methodist actually had a higher survival rate (84.6%) than the 21EAP (81%) in the same hospital. So my conclusion is the 81% survival rate as shown in 21EAP was not falsified.
The Seeking Alpha 8/11/2020 talked about the DSMB making recommendation based on first 30RCT results. We don't have the full result but we have 21 of them. These 21RCT result was unblinded, combined with the above open-label study/control group and shared with BARDA. Survival curves of the combined dataset were revealed in NRx S1 filing last December. I did a calculation at the time. 12/14 (85.7%) of Aviptadil arm survived 28days, 5/7 (71.4%) of placebo arm survived 28days. DSMB must be pretty optimistic when they saw the first 30RCT data.
So back to @12345's question 'So why were the clinical trial results so different from the prospectus study'. As far as the Aviptadil arm is concerned, you can see from above that the prospectus data is actually very inline with the RCT result in TH. To me there is no doubt Aviptadil works. Our result has clinical significance at the least. Only if we could recruit another 100 or so enrollees!
~ FC, Y@h00 RLFTF finance conversations
FC 49 minutes ago
@12345 you said "also in that article the DSMB suggested based on those open label results that 144 is possibly sufficient to achieve stat."
Now let's look how the SeekingAlpha articles says:
"On July 16, 2020, Relief Therapeutics and NeuroRx announced that the Data Monitoring Committee conducted a planned review of the first 30 patients treated in the Phase II/III Fast Track trial (Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure (COVID-AIV)). Per the release:
The committee determined that the study appeared capable of reaching a statistically significant endpoint within its 144 patient sample size and voted for the study to continue until its next scheduled evaluation in four weeks."
I don't know where you got the idea DSMB based the recommendation on the open-label study - that's certainly NOT what SeekingAlpha was saying.
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12345
123452 5 minutes ago
@FC i’m just reading the seeking alpha article not making any statements
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Lt. Francis
Lt. Francis31 minutes ago
@tito I wonder if the people who survived the ventilator ( and their loved ones ) feel it is Garbage?
Indisputable fact is people that would have died otherwise, lived to tell the story of Aviptadil.
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FC
FC 1 hour ago
@Kpags yeah disappointing to say the least. Hope NDA under the Accelerated Approval pathway will get us there. Any idea what other data is needed for this pathway and timeline?
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Kpags
Kpags 1 hour ago
The TH hospital mortality data comprising 70% of the trial was always what kept me optimistic of approval despite RH disaster. P<.006. Obviously it wasn’t enough for FDA but given the unmet need in this cohort it’s disappointing to say the least.
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FC
FC 2 hours ago
@12345 you got it wrong. DSMB didn't (and prohibited) use the open-label study to make their recommendation. DSMB had nothing to do with the open-label study. They based their recommendation on the first 30RCT result they reviewed. I mentioned that in my post and we knew the survival data on 21 of these 30 patients. At 28days it was 85.7% (A) : 71.4% (P). Just want to get this straight.
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12345
12345 2 hours ago
also in that article the DSMB suggested based on those open label results that 144 is possibly sufficient to achieve stat. They knew it was not random at that time and that the control groups could have been steered to the downside
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FC
FC 2 hours ago
I don't know if the FDA's risk concern has anything to do with the RH data. The RH's survival at 60days:
RH overall: 38% (A) 53% (P)
Aviptadil does look risky this way. But keep in mind RH patient numbers were small and in two of these hospitals all patients died. I don't know what happened in these hospitals. Did they not get enough training on administering the test drug? The Aviptadil arm in RH was only 40% of the one in TH, but they accounted for the same amount of death. Questions for physicians on this board, what might have caused this in your opinion?
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GizmoTime
GizmoTime 2 hours ago
Hence why the FDA needed more data because of the limits to make a confident conclusion of the effectiveness of the drug.
Reply1
FC
FC 2 hours ago
@tito did you not read the post? Houston Methodist had even higher survival rate in their RCT than the EAP study. But for someone who only understand gif, I can't ask for more. ugly low life. Mute
Reply3
tito
tito 2 hours ago
This drug failed. Face the facts. Houston Methodist numbers are not from a real study. They are expanded access patients. That is not intended to be a study. But it is a good pile of garbage from Dr. J. Spinning a story!
IS THE FDA/CDC STILL PUSHING VACCINE SHEET???
Study shows dramatic decline in effectiveness of all three COVID-19 vaccines over time
https://www.latimes.com/science/story/2021-11-04/study-shows-dramatic-decline-in-effectiveness-of-covid-19-vaccines
VACCINES FOR THEE BUT NOT FOR THE CDC???
Study shows dramatic decline in effectiveness of all three COVID-19 vaccines over time
https://www.latimes.com/science/story/2021-11-04/study-shows-dramatic-decline-in-effectiveness-of-covid-19-vaccines
CAN THE BEST OF VACCINES DO THIS???
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.
“I share the company’s vision for improving the lives of patients living with acute and rare medical conditions. I look forward to building Relief’s presence in the U.S., and to living the values of the organization with integrity, sensitivity, and humility each day.”
https://www.relieftherapeutics.com/newsblog/relief-therapeutics-announces-transitions-in-commercial-organization-to-implement-next-phase-of-corporate-development
“We believe that Zyesami has demonstrated a high degree of safety and a two-fold increase in the odds of surviving the ICU. Patients treated at the nation’s top hospitals with Zyesami had a four-fold increase in odds of survival. We will work actively with the FDA to deliver the data it has requested so that we may offer those patients another chance at life, and have asked the FDA for a Type A meeting that will include the experience of physicians who have witnessed the effects of our medicine firsthand,” Jonathan Javitt, M.D., chief executive officer of NRx said in a statement.
https://www.formularywatch.com/view/fda-rejects-eua-for-covid-19-respiratory-failure-therapy
CAN A FEDERAL COURT BLOCK THE ROBBERY OF A PATENT???
Vaccine mandate: Federal appeals court temporarily halts Biden’s vaccine rule
https://finance.yahoo.com/video/vaccine-mandate-federal-appeals-court-171231530.html
WHO ISSUED A LICENSE AND FOR WHAT PURPOSE???
And in November, the Thai government issued a compulsory license for an antiretroviral treatment for HIV without even warning the manufacturer.
Thailand's behavior is hardly unique. Across the world, it has been going on for years. China, for example, produces more patent rip-offs than any other country. And in India, the government recently passed an amendment denying patents to pharmaceuticals derived from "previous knowledge," a purposefully arbitrary phrase.
Meanwhile, Brazil and other Latin American countries have repeatedly threatened to use patent theft to strong-arm pharmaceutical companies.
Even worse, U.S. lawmakers are piling on. Last month, 22 members of Congress signed a letter to the U.S. trade representative expressing their support for the Thai government's renegade action. This is a slap in the face to pharmaceutical companies, whose expensive investments in drug research and technology ensure that these lifesaving medicines exist in the first place.
https://www.baltimoresun.com/news/bs-xpm-2007-02-20-0702200046-story.html
Last week, an Indian company began offering a generic form of the cholesterol-lowering Lipitor in Denmark, despite the fact that the creator of Lipitor still holds the patent. Although the Indian version was already available in India and some other emerging markets, Denmark is the first Western country to sell a copycat version of the drug.
The Strange Story Of Remdesivir, A Covid Drug That Doesn’t Work
https://www.forbes.com/sites/jvchamary/2021/01/31/remdesivir-covid-coronavirus/
NIH sponsored study made Remdesivir COVID-19 approval possible.
https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19
Injury to the liver of the COVID-19 patients???
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7386240/
ZYESAMI/RLF-100/AVIPTADIL is safe and has decades of studies/research. The FDA/CDC/NIH are slow-walking the safe/AMAZING NEUROPEPTIDE!!!
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.
https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic
Thank you, I will watch and pass it on.
Israel had a speedy vaccination!
https://www.reuters.com/world/middle-east/israel-sees-probable-link-between-pfizer-vaccine-small-number-myocarditis-cases-2021-06-01/
POLITICIANS vs DOCTORS
https://rumble.com/voqfdx-what-parents-need-to-know-before-jabbing-their-little-kids.html
Neurological Complications of Myocarditis
Rarely, stroke from myocarditis may also occur with a paucity of typical cardiac symptoms such as angina-like chest pain, heart failure, or perception of arrhythmias.
https://www.sciencedirect.com/science/article/abs/pii/B9780128198148000305
WHAT CAN AVIPTADIL/ZYESAMI/RLF-100 DO FOR YOU??? NOT MUCH UNTIL EUA/APPROVAL!
Congestive cardiac failure has become one of the major health challenges of the 21st century and new therapies are needed to address this problem. The concentration of vasoactive intestinal peptide (VIP) in the heart has been shown to decrease as fibrosis (the pathology leading to heart failure) increases and to become undetectable in end stage cardiomyopathy.
https://pubmed.ncbi.nlm.nih.gov/31449808/
IF ONLY GOVERNMENT HEALTH AGENCIES WOULD DEVELOP A SENSE OF URGENCY FOR OTHER THAN BIG PHARMA SOLUTIONS…
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.
https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic
Alzheimer's disease (AD) is a neurodegenerative disorder characterized by extracellular deposits of fibrillary ß-amyloid (Aß) plaques in the brain that initiate an inflammatory process resulting in neurodegeneration. The neuronal loss associated with AD results in gross atrophy of affected regions causing a progressive loss of cognitive ability and memory function, ultimately leading to dementia. Growing evidence suggests that vasoactive intestinal peptide (VIP) could be beneficial for various neurodegenerative diseases, including AD.
https://pubmed.ncbi.nlm.nih.gov/30498985/
The article, which argues that the scientific evidence does not yet justify giving most people third shots of messenger RNA vaccines, offers an insight into the internal tensions in the Biden administration that were ignited by the White House’s sudden decision to back the booster plan.
https://www.ft.com/content/af8da7d4-43ea-41d6-90ee-f959b3675cc5
WHAT COULD GO WRONG WITH GOVERNMENT GATEKEEPERS???
Aduhelm, Biogen’s monoclonal antibody drug to treat Alzheimer’s disease, was approved by the FDA on June 7, despite limited evidence that it actually works against the disease.
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A recent investigation by STAT News revealed that Biogen executives met multiple times with FDA officials through “back channels” in the months before the drug was approved.
https://www.forbes.com/sites/leahrosenbaum/2021/07/09/fda-commissioner-calls-for-inspector-general-probe-into-biogen-alzheimers-drug-approval/
WHAT, NO NEED FOR “BACK CHANNEL” MEETINGS…??? ALL BIG PHARMA!!! WHO THINKS THESE MULT-BILLION DOLLAR GOVERNMENT GIANTS NEED THE MONEY???
NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options ——— Health agencies, leading pharmaceutical companies to join forces to accelerate pandemic response.
WHAT CAN GO WRONG???
https://rumble.com/vkhxxf-canadian-doctors-who-speak-out-are-being-attacked-but-will-still-speak-and-.html
https://rumble.com/vddbul-2015-we-oppose-ca-sb277-parents-on-vaccine-injury-parental-rights-and-educa.html
https://rumble.com/vottor-interview-former-health-canada-pharmaceutical-adviser-on-regulatory-issues-.html
https://rumble.com/vov1dj-brilliant-university-professor-put-on-leave-over-non-disclosed-vaccine-stat.html
I would not be surprised if AVIPTADIL/ZYESAMI/RLF-100 corrects abnormalities in that gene.
Research by Dr. Ritchie Shoemaker has shown VIP corrects gene activation abnormalities in CIRS caused by exposure to water damaged buildings. Their research showed changes in genes controlling both ribosomes and mitochondria. Dr. Shoemaker has made testing for gene activity or suppression in relation to CIRS (ProgeneDx) availble at www.survivingmold.com.
Gene ID: 7432, updated on 29-Oct-2014, Also Known As: PHM27 The protein encoded by this gene (VIP) belongs to the glucagon family. Alternative splicing occurs at this locus and two transcript variants encoding distinct isoforms have been identified. GENE ID LINK
https://youarethehealer.org/mold-and-toxins/moldy-people/testing-for-mold-illness/vasoactive-intestinal-peptide/
But the FDA is slow walking/asking for more data on safe Zyesami while it warp speeds Big Pharma Remdesivir, Vaxx jabbers laced with nano particles and other preservatives.
https://rumble.com/vc9svf-nanoparticles-in-vaccines-and-neurological-harm.html
If you go first, you get to tell the world how lucky you all are at the CDC!!!
https://rumble.com/vnwss5-jab-mandate-victim-speaks-out-horrific-injuries-everyone-should-see.html
VACCINES FOR THEE BUT NOT FOR THE CDC??? AND NO, YOU DON’T GET TO PICK YOUR VACCINE LOT!!! LUCKY MEANS LUCKY!!!
ITS JUST A NEUROLOGICAL DISORDER, WHAT’S THE PROBLEM WITH THE CDC GOING FIRST??
https://rumble.com/vjuuz7-poway-mom-develops-rare-nerve-disorder-after-j-and-j-vaccine.html
YEARS OF TESTING??? ADD CAUSE FOR NEUROLOGICAL DISORDERS TO YOUR LIST/LOT!!! FEELING LUCKY???
Many types of products including cars, toys, and food products are sometimes recalled for short times or withdrawn permanently from the market because they don’t work properly or pose a safety risk. Although every vaccine goes through YEARS OF TESTING before being used, vaccines or vaccine lots (specific batches) can also be withdrawn or recalled.
https://www.cdc.gov/vaccinesafety/concerns/recalls.html
HOW ABOUT HAVING CDC EMPLOYEES GETTING VACCINATED FIRST, BEFORE THE GENERAL POPULATION???VACCINES FOR THEE BUT NOT FOR THE CDC???
PW, exactly! RAM and his RLFTF team may have seen this coming, perhaps before the first NRXP/JJ failure.
The CA is as good as the judicial court and jury where it will be seen. The government agencies and Big Pharma involved may be giant patent shoplifters as well. These giants pick winners and losers and so far we are bleeding!
We’ll see.
I did not see the FDA asking for more data/testing on toxic vaccines.
https://rumble.com/vk23ha-patient-asserts-sudden-neurological-disorder-caused-by-covid-vaccine.html
RLF-100/AVIPTADIL may help the afflicted with a neurological disorder after a toxic jab(s)
In the central and peripheral nervous system, vasoactive intestinal peptide (VIP), a 28-amino acid neuropeptide, is released to support neuronal survival in both physiological and pathological condition. VIP can inhibit the neurodegeneration induced by the loss of neurons.
https://pubmed.ncbi.nlm.nih.gov/27786097/
There is mounting evidence that VIP expression and signaling is altered in numerous neurological disorders, and it is becoming apparent that VIP and its receptors could be therapeutic loci for the treatment of several pathological conditions of the central nervous system. In this review, we describe the pathology of several major neurological disorders and discuss the potential pharmacotherapeutic role of VIP and its receptors for the treatment of disorders such as Alzheimers disease, Parkinsons disease, and Autism Spectrum Disorders.
https://www.eurekaselect.com/node/94030/article/-therapeutic-potential-of-vasoactive-intestinal-peptide-and-its-receptors-in-neurological-disorders
I am not selling, wasn’t a short play for me regardless of EUA. Aviptadil is a revolutionary treatment for ARDS, acute respiratory distress syndrome. Had COVID never come along, they would still be working toward the same end. Maybe they would have stayed away from Neuro and moved this faster in Europe, then US. I still see success on the horizon, just more distant. ARDS is a difficult to treat condition, once someone ends up on a vent, chances of survival decrease precipitously. Aviptadil can help prevent the vent and restore lung capacity. Stay the course, we made it this far.
~ Amanda, Y@h00 RLFTF finance conversations
Hello All,
First, I am 100% along the lines of @Amanda. I said just last week that for me I was working on everything outside of NRx and that the EUA would just be a bonus.
However, like everyone I read various sources and from what I have read here and elsewhere since last night news, I have these troubling questions :
1. Dr J has on his CV having worked at the FDA, yet he now has 2 failures, both of the same type : insufficient numbers or data, but mainly numbers of patients. No-one knows what Relief will do but I would not use him ever again to do work for my firm, and that is not taking into account the lawsuit and everything else he has done. Terms like "lazy", and "sloppy" come to mind but, perhaps worse, is how at this level can anyone make the same mistake twice, and a fundamental mistake at that : numbers, just numbers. If this was one of our contractors and I had ruled out "lazy" and "sloppy", I would be thinking "inability to scale up" and that means one or both of two things : using money incorrectly/wastefully, or the person does not have the management capability to properly scale up. Either option is no good.
2. I also saw a post where someone was troubled by the discrepancy between the figure quoted by the FDA, 131 patients, versus the one quoted in all NRx communications, 144. I did not quite catch on initially but I believe the poster is hinting at misinformation from NRx on the actual samples passed on to the FDA. If this proves correct then that is even worse than (1) above.
3. It will be interesting to see what the Market Makers do today. While many NRx investors will sell I am not so sure about Relief investors. I won't and by the sentiments of most I have seen on this board in the last 24 hours, it looks like most of us were no longer counting on the EUA anyway, and I certainly cannot see any institution selling. But where I am going with this is that, the silver lining on our non-EUA is that it gives Relief a massive advantage now in their negotiations with NRx as part of the court case : he has failed twice, returned ZERO, he is in an even worse place to be able to negotiate anything as far as I can see, so it will be interesting how that plays out and whether Market Makers cushion the drop because of that aspect.
With all the above in play, it will be interesting to see how it all moves because I fail to see an involvement of NRx in our future : fails twice in the same way and even tried to defraud us at the same time. Really !!!
Interesting next week or two.
~ IlkaS, Y@h00 RLFTF finance conversations
WHY WOULD CDC EMPLOYEES AVOID COVID-19 VACCINES???
You mean in your garbage rock, yes??? No???
Who is preaching, blah, blah, blah???
Type A meetings are necessary for proceeding with a stalled product development program or addressing an important related safety issue, according to the FDA. ... Following a Type A meeting, companies typically take the feedback from the meeting and use it to address the issues impeding drug development or approval.
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
I’m not preaching safety of the vaccine genius. Trip back to your cave!!
ZYESAMI/RLF-100/AVIPTADIL may very well be the countermeasure to avert a government/vaccine-induced disaster!
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.
https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic
One has to admire the ruthlessness of it all. Big Pharma, in conjunction with the heavy hand of government, pushes their vaccines which have been shown to be marginally effective in preventing COVID. Because of that, the call is now for booster shots upon boosters. But not to worry. If you do catch COVID, Big Pharma has brand new drugs to treat it. The pharmaceutical biggies get us coming and going. It's all so transparent. The true tragedy of this profit-making scheme is not the dollar cost to society, which is nothing to sneeze at. It's all the lives that have been unnecessarily lost since March 2020 and the adverse side effects from the COVID vaccines, the bulk of which won't be known for years.
https://www.americanthinker.com/blog/2021/10/rack_up_another_win_for_big_pharma.html
ZYESAMI/RLF-100/AVIPTADIL may very well be the countermeasure to avert a government/vaccine-induced disaster!
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.
https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic
How many decades of Covid-19’s vaccine data do we have???
First, let’s address the intelligence of the unvaccinated. Vaccine hesitancy is multi-factorial and has little to do with level of education or intelligence. Carnegie Mellon University did a study assessing vaccine hesitancy across educational levels. According to the study, what’s the educational level with the most vaccine hesitancy? Ph.D. level! Those can't all have been awarded to liberal arts majors. Clearly, scientists who can read the data and assess risk are among the least likely to take the mRNA vaccines.
https://www.americanthinker.com/articles/2021/10/the_unvaccinated_are_looking_smarter_every_week.html
Did he get the vaccine???
Are the answers in the data??? All data was evaluated by independent monitoring groups, yes??? No???
What are the long-term repercussions of the vaccine. The answers must be in the data.
You, an anonymous poster, care more than the scientists developing the vaccines???