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1) Next week, Houston Methodist hospital will provide update on critical ill patients and their outcomes. This is part of the Open Label study being done. He mentioned not to ruin the surprise but out of 5 patients on ECMO (Ventilators and very ill) 4 are alive. Dr Yosef to provide update next week.
2) Mentioned that in Brazil, doctors have already experience the great results on their patients from taking RLF 100
3) There is a new trial ready to start in September in regards to the INHALER form (VIP). They received FDA emergency designation on this.
4) No Safety Concerns on more than 100 patients that have been administered RLF 100. Not a single incident of adverse or safety concern with the drug.
5) Dr. Javitt met with the FDA last week and the outcome was a very positive scientific discussion.
6) Dr. Javitt is very connected and has the respect of the FDA based on his work and experience. He mentioned that his investigation drug application was approved by FDA within 48 hours when it can take weeks or months. He also mentioned that he requested to meet with the FDA. This usually takes up to 60 days to receive a response. He received response from FDA within 1 week.
7) RLF 100 is being administered in Houston, Miami, Kentucky, California. By the end of month should be at more than 10 hospitals.
8) Ready to announce a partnership with a BIG PHARMA for manufactured and distribution
9) We are about to receive an update by the Data Monitoring Committee on the trial taking place.
10) Provided evidence in X rays as to how the drug has helped critically ill patients go through a rapid recovery.
We build our manufacturing to scale and we’re about to announce a partnership with the largest supplier of inhaled sterile drugs in the US and about to announce a partnership with a very large well known public company that can get any drug to any hospital overnight, so yes we’ve built this to scale
it’s gonna be in more than 10 hospitals
met with FDA last week, very positive scientific meeting, worked with FDA for 35 years, I’m astounded by how they’ve turned on a dime and focused themselves 100% on how to get Covid treatments to the market quicker
* FDA actually approved our IND application (which allows you to test drugs in humans) in less than 48 hours. When asked to meet with them they’ve met me in less than a week when typically 60 days is the standard meeting request time.
* Worked for 4 US Presidents, worked in the FDA for the commissioner, worked in the industry for companies trying to bring drugs through the FDA, and I’ve been a professor advising the FDA so I’ve seen them from all sides.
* On our board we have a former chief Counsel of the FDA and a former Associate Commissioner of the FDA
* When that phone call does come to tell you that they have approved your drug, the FDA is even more excited then you are.
* In terms of our trials next week will be reporting data on 21 patients from Houston Methodist trial.
* Currently 86/87 patients today but once were at 102 patients next week our Independent Data Safety Board will give us their update.
Check the interview with dr. Yo
video with Dr. Yo and Dr. Javitt. He mentions the partnerships coming just after the 35 minute mark.
It's actually two different companies they will be partnering with. One with the largest supplier of inhaled drugs, and one with a large company that distributes drugs. Making it possible by October to be able to supply around 100,000 people per month with the drug.
Also important that Dr. Javitt said that so far, with about 85 patients in the trial, there have been very little side affects and mostly good results. We should hear something next week.
Very exciting!
Data from the Dr. Javitt interview showed significant reduction of inflammatory cytokines levels in Covid19 patients treated with RLF100 (50% - 100%). This fact from the many from the the interview is so incredible. you need to see it to appreciate what we have here.
Let that sink in....
Partnership is comin!
Javitt "We are about to announce a partnership with a very large, public company that can get drugs to any hospital overnight". In regards to scalability.
timeline: according to the doctor.....> He just met with the FDA last week, and had a very productive scientific discussion with them about this....
THAT, sounds very promising.
"Very impressive results"
"Next week: more news"
"21 patient data come out next week"
Just said "Next week you'll see similar results in 21 more patients" Already have those results so it has happened twice now.
"Extraordinary results"
"We are excited"
He said next week 21 more cases like the slides he showed today should become available thru Houston Medical. He said the full placebo controlled study already has 80 something, I think he said 86, patients enrolled. And that is an expedited trial. Things are moving along quickly. Note: Tomorrow is the end of the 4 weeks referenced mid July, so late this week or next week as the doctor here says could get interesting for share price. Long & Strong! GLTA
Boomshakalaka !!!!
History in the making...
https://twitter.com/YoDoctorYo
Interview right now at dr. YO
Great DD Tendies!
Dr. Yo! Interview today is going to be that steroid shot we need from all these fools selling their gold for pennies! This is going to go far up from here very soon, looks like most of the bio sector is down it's not just us hold strong and long!
with approval: instant multiple dollars...a lot will be chasing...
❗️Off-label use of RLF 100 in India.
— Siddhartha| सिद्धार्थ| సిద్ధార్థ (@das_seed) August 11, 2020
NeuroRx has been granted Investigational New Drug (IND) permission by @US_FDA to test RLF-100 for inhaled use in patients with moderate and severe #COVID19 in order to prevent progression to respiratory failure. 🧐
Image via @sandhyafernez pic.twitter.com/jMOcCrTq8A
Buy as much as your money can take you and wait for FDA approval....it will come for sure!
RLF is the real thing and we will see multiple dollars very, very soon!
Article published today.. WOW... COVID KILLER plus preventing transplant rejection = magic pill
https://seekingalpha.com/article/4367483-relief-therapeutics-discovers-promising-covidminus-19-killer
buy and HOLD!
Summary
Relief Therapeutics is in advanced clinical trials with their drug RLF-100 which aims to halt COVID-19 and reverse its devastating effects;
Just-released Compassionate Use results showed stunning results: ventilator-dependent Covid-19 patients with deadly co-morbidities coming off the ventilator and returning home in only five days after treatment with RLF-100;
Relief Therapeutic's RLF-100 is both easy to manufacture at scale and inexpensive, meaning that success in clinical trials could translate to rapid worldwide production and availability;
If in-progress clinical trials reflect the Compassionate Use results, RLF-100 will likely garner immediate approval and shares could go much higher.
Relief Therapeutics Holdings AG (OTCPK:RLFTF) is a Swiss Company that trades on the U.S. OTC Exchange in addition to its Swiss Stock Exchange Listing (RLF). Only a week ago, Relief Therapeutics was trading under .10 per share. It was the rediscovery of the properties of their drug RLF-100, a proprietary synthetic form of Vasoactive Intestinal Polypeptide (VIP) also known as aviptadil, which has led to the justifiable interest in the company.
In a previous article, I described my rationale for following potential Covid-19 therapeutics over potential vaccines, and the progression of the disease from viral to immunologic that has served to categorize the various approaches to fighting Covid-19 and its effects. I won’t repeat that discussion here, as I'm eager to get to the point that Relief Therapeutics’ drug is the most promising that I have encountered to tackle Covid-19 in four months of research.
Let’s start with the latest results, then get to the science, followed by Relief Therapeutics’ corporate structure, management and balance sheet.
The Results So Far
On August 2, 2020, Relief Therapeutics announced a report from doctors at Houston Methodist Hospital that RLF-100 “showed rapid recovery from respiratory failure in the most critically ill patients with COVID-19.”
At the same time, unaffiliated independent researchers working in Brazil reported that VIP inhibits the replication of SARS-CoV-2 virus in human lung cells and immune cells.
The release from Relief and NeuroRx further stated:
The report describes a 54-year-old man who developed COVID-19 while being treated for rejection of a double lung transplant and who came off a ventilator within four days. Similar results were subsequently seen in more than 15 patients [emphasis mine] treated under emergency use IND and an FDA expanded access protocol, which is open to patients too ill to be admitted to the ongoing Phase 2/3 FDA trial.
Patients with Critical COVID-19 were seen to have a rapid clearing of classic pneumonitis findings on x-ray, accompanied by an improvement in blood oxygen and a 50% or greater average decrease in laboratory markers associated with COVID-19 inflammation.
Professor Jonathan Javitt, Chairman and CEO of Relief’s U.S. partner NeuroRx stated,
No other antiviral agent has demonstrated rapid recovery from viral infection and demonstrated laboratory inhibition of viral replication.
Per the pre-print report authored by doctors at the Houston Methodist Pulmonary Transplant Center and the Houston Methodist Department of Academic Pulmonology, the patient was suffering from rejection of his double-lung transplant, and then on top of this was diagnosed with COVID-19. Despite the use of all currently available therapies (with the exception of Remdesivir due to the patient's chronic kidney disease), the patient’s condition continued to decline. Within 24 hours of treatment, substantial improvement in oxygen saturation and radiographic improvement in characteristic COVID-19 pneumonitis was noted. He was discharged from intensive care in 5 days after the third infusion and went home on room air.
I read this paper numerous times, because what is specifically so promising to me is the patient’s initial condition and of course their rapid recovery time. Double lung transplant rejection and COVID-19 seems to have been vanquished at the same time by RLF-100.
Could this mean that RLF-100 might have a role in preventing transplant rejection as well? The paper’s authors indicate they think so. They write:
VIP may have been particularly beneficial in the setting of AMR [Antibody-Mediated Rejection] following lung transplantation based on prior reports that VIP preserves the function of lung allografts. VIP is a potent anti-cytokine in the lung that provides key defense against numerous forms of acute lung injury.
If this is the case, we are talking about an additional important role for RLF-100, AMR. This is a situation that can occur with organ transplants, such as lungs, liver, and kidney, causing organ failure. But right now, the focus necessarily must be on COVID-19.
We need clinical trial results to make an educated decision about whether RLF-100 can be successful in fighting COVID-19. Recent results from the expanded access trial have been stunning and very exciting. Further confirmation could be an absolute victory for the world. Not only could we have a drug that can vastly reduce death and disability from COVID-19, Relief Therapeutics reports that RLF-100 is relatively easy to produce, and far less expensive than many competing therapeutics. This means a drug with rapid global availability and accessibility, even impoverished nations with a vast need for cost-effective medications.
Aviptadil has seen prior success in ARDS induced by sepsis, according to Relief Therapeutics. The company states that in a Phase I trial
…8 patients with severe ARDS on mechanical ventilation were treated with ascending doses of VIP. Seven of the 8 patients were successfully extubated and were alive at the five-day timepoint. Six left the hospital and one died of an unrelated cardiac event. [source: Relief Therapeutics Website]
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.
This appears to be a tremendous vote of confidence from the Data Monitoring Committee. Not only did they recommend that the study continue, after only 30 patients they determined that statistical significance appears to be reachable within the 144 patients in the trial. According to Relief Therapeutics and NeuroRx, “[the] Data Monitoring Committee determined that so far RLF-100 has generated no drug-related Serious Adverse Events or other safety concerns that would mandate stopping.”
Of note, the Data Monitoring Committee is composed of the following individuals: 1. Professor Alfred Sommer, MD, MHS, Dean Emeritus of the Johns Hopkins Bloomberg School of Public Health; 2. Professor Rita Colwell, PhD, former Director of the National Science Foundation; and 3. Congressman Andy Harris, MD, MHS (MD District 1), also part-time Professor of Anesthesia and Critical Care at Johns Hopkins School of Medicine.
Coming Data Points
Based upon the companies’ July 16 release, the DMC will evaluate the patient data in the Phase II/III Critical patient study again “in four weeks,” which puts the next possible data release on about August 13, Thursday of this week.
The Science
First I’d like to go step-by-step and describe how COVID-19 is believed to attack the body, and then describe RLF-100’s proposed method of action.
How COVID-19 attacks the body and causes disabilities:
COVID-19 attacks type 2 alveolar cells (AT-II) in the lungs, intruding by binding to ACE2 receptors on the AT-II cells. Once inside, COVID-19 replicates millions of viral particles, ultimately causing cell rupture;
These AT-II cells are key to protecting the ability of the lung cells to engage in the gas transfer process, getting oxygen into the bloodstream, by secreting pulmonary surfactant, lowers surface tension at the air/liquid interface within the alveoli, which protects the alveoli during the crucial oxygen transfer process and prevents the alveoli from collapse.
The destruction of these AT-II lung cells by COVID-19 reduces the production of pulmonary surfactants, decreasing lung function because oxygen is no longer being transferred into the blood, and carbon dioxide is no longer being transferred out of your lungs by the alveoli. [Gas Exchange summary video]. This gas exchange is essential for survival.
COVID-19’s occupancy of the ACE2 receptor might also affect Angiotensin II conversion, increasing vasoconstriction and blood pressure, and cytokine release from angiotensin receptor (ATR-1) expressing cells.
The Cytokine Release Syndrome (CRS), also known as the Cytokine Storm, which is the body’s out-of-control immune system activation as a result of the COVID-19 invasion, further weakens the walls of blood cells and allows for leakage of fluids into the lungs, causing the lungs to fill with fluid (pulmonary edema). Pulmonary edema further incapacitates the alveoli and prevents normal oxygen transfer.
In summary, COVID-19 directly targets and incapacitates certain lung cells, causing a domino effect of severe trauma to the lungs, and the body’s response via an out of control immune system response can further exacerbate the trauma.
As we all know too well, a solution has been elusive.
With RLF-100, a solution may be at hand.
What is RLF-100 and how does it fight COVID-19?
RLF-100, also known as aviptadil, is Relief Therapeutics’ synthetic form of Vasoactive Intestinal Polypeptide (VIP). VIP is an endogenous polypeptide, endogenous meaning it originates within the human body. A polypeptide is generally a large number of amino acids bonded together in a chain, to form a substance such as a protein. Other Examples of polypeptides are insulin and growth hormone.
Here is how Relief Therapeutics and NeuroRx describe the function of RLF-100:
VIP binds to VPAC1 receptors on the pulmonary Alveolar Type II (ATII) cell. ATII cells comprise only 5% of lung epithelial cells but are critical for oxygen transfer, surfactant production, and maintenance of Alveolar Type 1 cells. 70% of VIP binds to this receptor. The Type II cell is also the cell selectively attacked by the SARS-CoV-2 virus via the ACE2 surface receptor.
Nonclinical studies demonstrate that VIP is highly concentrated in the lung and specifically bound to the ATII cell, where it prevents NMDA-induced caspase-3 activation in the lung, inhibits IL6 and TNFa production, protects against HCl-induced pulmonary edema, and upregulates surfactant production, These and other effects have been observed in numerous animal model systems of lung injury in mice, rats, guinea pigs, sheep, swine, and dogs. In these models, Aviptadil restores barrier function at the endothelial/alveolar interface and thereby protects the lung and other organs from failure.” [source: Clinical Trial NCT04311697]
In their most recent clinical trial description for the “Inhaled Aviptadil for the Treatment of Moderate and Severe COVID-19” trial, NeuroRx and Relief state:
Vasoactive Intestinal Peptide (VIP) is known to target the VPAC1 receptor of the ATII cell and to protect that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents. VIP prevents apoptosis, blocks cytokines, lowers TNFa levels, reverses CD4/CD8 ratio, and reduces cough and dyspnea in nonclinical and clinical studies.
In keeping with the Brazil scientists’ recent discovery that VIP suppresses the ability of SARS-CoV-2 to replicate in human lung cells[1], RLF-100 could essentially render COVID-19 powerless.
The method of action of RLF-100 can be summarized as follows:
After binding to the AT-II epithelial lung cells at the cells’ surface receptors, RLF-100 does the following:
suppresses replication of the SARS-CoV-2 virus in human lung cells;
prevents damage to the lung alveoli gas exchange process;
upregulates the surfactant production ability and epithelium replenishment ability of the AT-II cells, protecting lung cells from damage;
prevents hypertension and vasoconstriction that leads to alveoli cell wall weakening and pulmonary edema;
Potentially vital to the effects of RLF-100 is that it inhibits various pro-inflammatory cytokines in the lungs, possibly halting and/or reversing the cytokine storm.
RLF-100 also reverses the CD4/CD8 ratio, which is a measure of the strength of the immune system.
grab all you can here.....going to multiple dollars and everyone knows!
Can’t help thinking some are over thinking this. Before last Month people could have bought a million shares at 10,000. This morning in Switzerland we some sell off and then all those who bought last week at.60+ panicked. Within 15 minutes there were large buys at .15 taking it back to .40. The only people who lost out are the panickers. This stock will depend on the clinical trial and FDA results or a partnership. .... Now real investors are in play......
Q will drop...going to dimes!
Here you have NVAX that has gone from $4 to $170 in 52 weeks and has yet to have a vaccine approved. RLFTF has fast track approval with a proven safety record sitting at .62 , let that sink in!
Buy and HOLD
The news is spreading....
BUY ALL YOU CAN HERE :)
In Europe now: UP 58 % and GREAT MASSIVE volume...95 mio dollars already trade within 3 hours....
up 45% IN Europe....just hold and relax.....going to dollars for sure....
incredible volume!.....60 mio dollars in just two hours...
I Agree Tendies....no pullback here....hold your shares with a kungfu grip....
Some people are missing the big picture on this. If this works like they say it does let me lay out what probably will happen. The US government with leverage the defense production act to buy up the first 30-50 million doses. They will give/loan the company possibly hundreds of millions of dollars to get production ramped up ASAP. Foreign governments subsequently will have to bid for doses following the US governments initial buy up. But what people are missing, models predict 300k covid deaths in the USA by December 1st. That is terrible optics for the Republican Party who are in threat of losing the Presidency and the senate. They need the win in November and they will write blank checks backed by the American tax payers to make sure it happens. If this drug can stop 80% of the deaths from happening, well... that’s their golden ticket to re-election.
All IMO. But we are in no regular stock right now. We are share holders in a company that might reverse the most economically devastating global event of our generation. (Other than global warming etc). The US government is hemmoraging money right now, that’s why they are pushing so hard to re-open. The country could be bankrupt from this if something isn’t done soon.
If this drug turns out to be the cure the world is looking for, and it get final FDA approval, then why couldn't we see $1,000 per share plus? There is a potential for the company to make tens, if not hundreds of billions of dollars. This drug could be a life saver and folks: When more positive results are comin - the sky is really the limit...
News is all over the world now...here in Europe IT is a big thing...stock RLF is on the the Switzerland market at 0,40 right now...the market opens in two hours...watch IT explode to dollars today already...this has nothing to do with ihub anymore...
Tomorrow first dollar....more to follow
Ten bagger short time
More than 70 mio $ traded already in Europe!
Do better DD..
This company has a quote in Europe (Switzerland) and in Canada....same company...better buy all you can, because we will see multiple dollars very very soon