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Thanks Deckard!
Ahhh... "vaso dilating" is the term I couldn't recall. Yep... that's what Javitt was describing.
True "we only know of 21 patients"... but perhaps these couple unofficial observations can help put some additional background to it...
- My understanding is the fda typically looks for a pval of P=<.001 (or maybe it was only P=<.01 if I recall - and I'm hoping someone can point us to an official source). Albeit a small sample, the 21 patients came in at P=<.0001, so quite a bit better.
- Remember when Javitt was discussing the 9-fold efficacy over soc, he also stated that there were more data they're seeing from the open label study and it is in line with the results from the 21. He seemed pretty certain the results are not the worlds largest placebo effect.
Sorry... I don't have all my facts and sources in front of me, but these are the points I do consider above the official info... given it comes from Javitt.
Yeah... iHub has a 1980's clunkiness to it... but technically, its better due to the search tools, ability to pin, ability to post links, etc. Many advantages despite its awful clunkiness.
Goodness... it would be dangerous for me to explain it... I'm no medical expert, but Dr. Javitt explained it in one of his videos and mentioned that its not the same (perhaps someone has the clip of that?). If I recall, it works more like the erectile dysfunction version, where it opens up some oxygenation, but not in the right places. It is a VIP, but not implemented to target the lungs and side effects. To do that, you have to have RLF100... cuz we have the patent on it.
Because we have picked up PLENTY of new investors along the way who have not done their DD and just bought on the hopes of a pop based on something someone told them or something they read. This is obvious if you look at all the confusion on YHoo board. And because those people do not know the company and situation well enough, they panic very easily. They will be back in buying mode once the dust settles and their emotions swing to the other direction.
P.S. This is why I have spent time putting together resources for new investors... to at least raise their level of knowledge a bit, so we can dampen some of the ridiculous wild swings. Please feel free to reuse my posts in any way you see fit.
Guy... I'm hoping... if we get a moderator to relinquish their role, that you would be willing to step into it, as I believe you would do a fantastic job. Level headed and we need someone who can guide investors to legitimate sources.
Nah... I see how that might seem logical, but here are a couple things that need to be taken into account...
First, if you recall, the way that drug works is completely different than RLF100... RLF100 hits the lungs directly and protects the ACE2 cells and knocks out all the deadly side effects. Their drug does not... which is why it isn't very effective.
The other thing to consider is that we need a MUCH lower number of cases, because our P-Value is exceptional, due to the superior efficacy... so statistically, we don't need nearly as many cases to get a very strong P-Value.
We're the only game in town ;)
Hahaha... I stepped away for several hours after the bell and came back THIS! WOW!
GREAT News! The FDA DAM HAS BEEN BROKEN! AND THE BAR HAS BEEN SET SOOOO LOW, that my dead grandmother CAN STEP OVER IT!!! Now it will be up to Good Ole Fashion competition and science to prevail! Here we go guys!!!
Nahhh... there's nothing around the corner lol
Welcome. I think you'll find there are no expert schemer's running this project. Once you've had a chance to review the pedigree and actions to date, I think you'll agree.
Also, I was just thinking earlier today, that when we get the EUA, there will be many people flocking to catch the initial jump in sp, but few will realize the depth of what we have here for quite some time, as it's a lot to absorb. This story has depth, and it will take a while to unfold, but the investors who have been here understand its a best seller.
Let us know how we can help.
Ha! That would be cool.
This is an excellent and accurate description of Dr. Javitt... well said!
"I find him more than humble, willing to credit people for their work so much so he interrupts interviewers to make the distinctions and is always cognizant of placing the burden on Science not on his personal hopes or whims. He never leans out over his skis in interviews. He is a straight shooter with a kind and gracious demeanor, In my assessment of him."
Well... "live" may not be the right term... try "dead" or "asleep" :D
Awesome digging my friend! And in regards to the $73.89... that’s certainly a number I’d like to see! :D
It just goes to show we really have no idea what we have on our hands.
Dang fool don't know his own stock
Thanks ;) We're all in this together and need to be realistic on expectations.
Susan... that's her... let's hope she finds the "evidence was overwhelming".
Well... but he did start off saying they "expect to read-out the Phase 3 trial by the end of the year", indicating Relief and Neuro plan to continue the trial, but that he strongly believes it will be stopped sooner.
Ahh... your right... FDA thanks for the correction.
I am going to post this on Yhoo. I've said a lot of this already on this board, but in case you missed it...
My thoughts on Approval Timeline…
There’s a LOT of guessing of when people “think” or “believe” an announcement will come, and whether that will be EUA or full FDA approval. Let’s take a more structured approach to analyze the expected timeline through Javitt’s comments during his most-recent presentation last Thursday, Oct 15th in the Solebury Trout Webcast. Javitt said…
“The Covid study is moving forward with incredible velocity. We expect to read-out the Phase 3 trial by the end of the year. But, ah, 2 weeks from now, there's going to be a meeting of the data safety monitoring board (DSMB). And ah, they're going to review the first 102 patients in the trial. They have the potential to see both futility, which we hope they won't see. Or perhaps they will see overwhelming evidence of efficacy. Either, which would lead to stopping the trial.”
Now… let’s unpack this and take a closer look at his words:
---
First, he said the DSMB will meet “2 weeks from now”.
Notice he did NOT say “in EXACLY 2 weeks from now”. I was not able to find a date for the DSMB meeting, so given he said those words on Thursday, we can assume the DSMB should be meeting somewhere within the last several days of October or the first several days of November.
---
Then he said… “And ah, they're going to review the first 102 patients in the trial.”
Now, I don’t know how these meetings work, so I have questions regarding the decision-making process…
Will all the decision makers be familiar with the data by the time they get to the meeting, and therefore, they are prepared to discuss the first 102 patients right then and make a decision?
-OR-
Is someone else preparing the data and presenting it at the meeting for the decision makers to have a “first-look” at the data, and therefore more time will be needed to discuss and make a decision?
Also, is the meeting public, so we can hear the determination first-hand? Or is the meeting private and will need to wait for an official announcement to be prepared?
---
Then he said… “They have the potential to see both futility, which we hope they won't see. Or perhaps they will see overwhelming evidence of efficacy.”
The fact that Javitt only gave 2 outcomes (and excluded a potential 3rd option of “needing more data”), and the fact that he described option 2 as “OVERWHELMING evidence of efficacy”, I think it is safe to assume he is more-than-confident that the DSMB will see overwhelming evidence of efficacy in the data.
---
Then he said… “Either, which would lead to stopping the trial.”
This statement tells me he is fully expecting the trial to be stopped, based on overwhelming evidence of efficacy. It would be unethical to continue the trials until the end of the year and continue giving half the patients a placebo, leaving them with a much greater chance to die… but more importantly, it would be unethical to continue the trials, leaving all the other critical patients across the United States from now until the end of the year to die.
---
So here’s my assessment:
I think the DSMB is going to give EUA approval first… this will expand the drug to all critical patients in the USA. Then shortly after, it becomes SOC (standard of care). During that time, the FDA has the opportunity to observe results before giving full FDA approval by year end or January.
So… a decision to stop the trial is coming, along with EUA. It could come as early as next week, or if the DSMB meeting process requires review, then discussion, then decision-making, then official announcement… it could be as late as mid-November.
My personal opinion is if EUA doesn’t happen next week, then it will happen by Nov 5th at the latest.
We are so close! Have patience my investing brothers and sisters.
You're welcome... the more eyes searching, the better.
For those who are relatively new and thus may not have seen this... it is a google search I built for all RLFTF news in the past 24 hours. I use it daily in the morning to check news articles that may mention us. I recommend saving the link somewhere.
(let me know if it doesn't work for you)
CAUTION: There are some articles that are auto-generated - they generate automated news content for the purpose of generating advertising revenue (click bait)... that's not what you're looking for... you're looking for REAL human journalism.
https://www.google.com/search?rlz=1C1CHBF_enUS704US711&biw=1527&bih=854&tbs=qdr%3Ad&tbm=nws&ei=ntpGX83xEe-I5wLm9qWIBw&q=%22aviptadil%22+OR+%22rlftf%22+OR+%22RLF-100%22+OR+%22relief+therapeutics%22&oq=%22aviptadil%22+OR+%22rlftf%22+OR+%22RLF-100%22+OR+%22relief+therapeutics%22&gs_l=psy-ab.3...1891.35602.0.36024.56.42.13.0.0.0.167.3851.28j12.40.0....0...1c.1.64.psy-ab..4.13.1280...0i333k1j33i299k1j33i10k1.0.SBeEdcWi-6w
Yeah... nothing against Russians... I'm not like that... I just don't have much faith in vaccines in general given the complexities of covid.
And/Or Big Pharma who are incapable of producing anything effective... I doubt Russia has an effective vaccine, but they certainly seem to be profiting from it.
You are misinterpreting the headline. See explanation...
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=158925850
No... the wording is technically correct, but could easily be misinterpreted that they are merging. The author should have been a bit more careful, but it is technically correct.
It will be fun watching the long-term evolution, knowing we were in during the early stages.
Interesting... yeah page 3 verifies your WIPO discovery. I wonder the status of all this stuff.
Wow... why so many I wonder?
With the large influx of new retail investors, there has been plenty of confusion and misinformation on financial forums and social media about Relief Therapeutics. To help clear things up, I’ve compiled an accurate summary of key DD below (with sources).
Please help spread accuracy by sharing this post on financial platforms and social media.
DD by Uncle Gee Gee (updated Oct 2, 2020)
Every RLF-100 Investor Should Read
EXECUTIVE SUMMARY
Relief Therapeutics is a small Swiss company with a patent for a drug called RLF-100 that treats Covid-19 patients. RLF-100 is a safe, synthetic version of a naturally-occurring peptide in the human body.
Relief Therapeutics has partnered with NeuroRX (led by CEO Dr. Javitt) for assistance with the U.S. FDA process, as well as manufacturing and distribution within the United States, Canada and Israel. Operations for the rest of the world will be handled separately by Relief Therapeutics.
RLF-100 has 4 clinical trials underway, and initial results look exceptionally promising. Highlights are provided below.
AVIPTADIL RLF-100 VIP
• VIP (vasoactive intestinal polypeptide) is a naturally occurring peptide in the human body.
• Aviptadil is a VIP for the treatment of erectile dysfunction, proven to be safe since 1970’s.
• Aviptadil is being repurposed as RLF-100 to treat Covid-19 patients.
• RLF-100 is a safe, patented, synthetic form of VIP, which increases surfactant production in the lungs to protect against Covid-19.
• RLF-100 is a trifecta treatment: 1) It blocks Covid-19 from attaching to host cells in the lungs; 2) it prevents the cytokine storm; and 3) it reduces inflammation.
• RLF-100 has 4 separate clinical trials for intravenous and inhaler versions of the drug.
• RLF-100 is inexpensive and easy to manufacture.
• RLF-100 shows promise for other lung applications beyond Covid, which also need to be studied and tested separately.
STOCK / COMPANY
• Relief Therapeutics is a small company in Switzerland that holds the patent on RLF-100.
• Relief is traded over the counter (OTC) on the Swiss SIX exchange.
• In August 2020, Relief up-listed from “OTC Pink” to the higher-tier “OTCQB” to allow a broader range of investors. Relief intends to seek a future presence on the NASDAQ or NYSE.
• Relief has CHF $48M cash on hand ($52M USD), enough to support planned trials and operations through 2022, without taking into account any RLF-100 revenue.
• NeuroRX is a private US-based partner and has connections at the highest levels of government and big pharma. They are guiding Relief Therapeutics through the FDA approval process and organizing manufacturing and distribution.
• Relief and NeuroRX will split profits from sales: 50/50 for U.S., Canada and Israel, 85/15 (in favor of Relief) in Europe, and 80/20 (in favor of Relief) in all other territories.
Leadership Team: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=158200526
Partnership Agreement: https://relieftherapeutics.com/relief-and-neurorx-announce-partnership-for-global-commercialization-of-rlf-100-and-selection-of-commercial-partners/
Funding: https://relieftherapeutics.com/relief-announces-capital-increase-from-its-final-tranche-of-the-share-subscription-facility-with-gem/
OTCQB Uplisting: https://relieftherapeutics.com/relief-announces-successful-up-listing-from-otc-pink-to-otcqb-and-capital-increase-from-its-share-subscription-facility-with-gem/
MANUFACTURING & DISTRIBUTION
• Robert Bestoff is the Chief of Operations and spent his career at Lilly & Pfizer. At Pfizer, he was head of the entire neuro science and pain division, responsible for $10B of drugs.
• Rich Siegel, former head of Johnson & Johnson’s drug portfolio, put together the manufacturing program.
• NeuroRX has signed 3 contracts in preparation to treat up to 1 million patients:
1) Bachem Americas has been contracted to manufacture drug substance for RLF-100.
2) Nephron Pharmaceuticals has been contracted to manufacture commercial supplies of RLF-100.
3) The largest supplier of inhaled sterile drugs in the United States, able to supply RLF-100 to any US hospital overnight, has been contracted as the pharmaceutical logistics partner.
M&D Contracts: https://relieftherapeutics.com/neurorx-and-relief-therapeutics-establish-supply-and-distribution-agreements-for-rlf-100-aviptadil-2/
CLINICAL TRIALS
Relief has the following 4 clinical trials underway:
1) Clinical Trial NCT04311697 – IV Trial
• This trial is for intravenous RLF-100 administered to patients in ICUs with respiratory failure.
• The trial seeks to enroll 144 patients.
• The trial is currently in “Phase 2b/3”, meaning it will evaluate both dosing and efficacy.
• A first interim review was held at 30 patients, which determined RLF-100 is safe for human use.
• A second interim review will be held at 102 patients with a determination to: 1) stop the trial because the drug is dangerous, 2) stop the trial because the drug shows no effect, 3) continue the trial because results look good, 4) stop the trial because the drug is proven.
• Patient #102 was enrolled on 9/30/2020; therefore once that patient completes their trial (28 days later), the Data Monitoring Committee (DMC) will review results and submit a recommendation to the FDA.
• Doctor (and Congressman) Andy Harris is 1 of 3 experts on the DMC.
First Interim Review: https://relieftherapeutics.com/neurorx-and-relief-therapeutics-announce-data-monitoring-committee-determination-to-continue-phase-2-3-trial-of-rlf-100-for-critical-covid-19/
2) Clinical Trial NCT04453839 – EAP Trial
• This EAP (Expanded Access Protocol) trial allows RLF-100 to be used as a last-resort for patients too sick for regular trial participation (commonly referred to as "compassionate use").
• EAP is NOT the same as EUA (Emergency Use Authorization) – see clarification below
• Early EAP results were released in a “pre-print” document for patients considered to be “the sickest of the sick” (ICU, ventilator, ECMO patients).
• Results: For patients who received RLF-100, 19 out of 21 patients survived, where only about 6 were expected to survive.
Initial EAP Results Pre-print: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3665228
Clarification: EAP and EUA
• EAP = Expanded Access Protocol – currently approved
• EUA = Emergency Use Authorization – submitted application to FDA
• EAP allows RLF-100 to be used as a last-resort for patients too sick for regular trial participation.
• Qualifying for EAP is limited: the patient must be located at one of the few clinical trial hospitals, or transfer to a participating hospital, or have the hospital attempt to qualify for the drug.
• Due to EAP limitations, NeuroRX recently applied for EUA and is awaiting FDA approval.
• EUA allows experimental drug use during public health emergencies. Qualifications are that the drug must be safe and “may” be effective.
• If approved, EUA will allow RLF-100 to be used at all US hospitals, as a last resort when all other approved treatments have failed.
• EUA approval is not necessarily dependent upon trial completion or interim reviews, unless FDA subsequently requests more data.
• Currently there are only 2 other EUA approved therapeutics: Remdesivir and Convalescent Plasma.
EUA Submittal: https://relieftherapeutics.com/relief-partner-neurorx-submits-request-for-emergency-use-authorization-for-rlf-100-aviptadil-in-the-treatment-of-patients-with-critical-covid-19-and-respiratory-failure-who-have-exhausted-a/
Other Approved EUAs: https://www.fda.gov/media/136832/download
3) Clinical Trial NCT04360096 – Treatment Inhaler
• This trial is a study of 288 patients in the United States to test an inhaler-version of RLF-100, intended to ultimately be used for in-home nebulizer treatments.
• Dr. Javitt: “We expect that half the people we enroll in our inhaled study are going to be people who are outpatients.”
• Current estimated completion in 2020
4) Clinical Trial NCT04536350 – Preventative Inhaler
• This trial is a study of 80 patients in Switzerland to test an inhaler-version of RLF-100 as a “preventative treatment”.
• Current estimated completion in December 2021
Link to all 4 trials: https://clinicaltrials.gov/ct2/results?term=Aviptadil&draw=2&rank=1#rowId0
OTHER EFFORTS
• Signed a cooperative agreement with NIH’s Institute of Arthritis and Infectious Diseases to test RLF-100 “against the flu virus and other viruses that kill people by attacking the lungs.”
• Israel has already granted Companionate Care Protocol across the country, and NeuroRX is in the process of determining how to serve it.
• When asked whether FDA approval would have an impact on other countries, Dr. Javitt responded with “the FDA determinations are highly influential around the globe”.
Yo Dr. Yo – Interview 1 on 8/12/2020:
This is terrible news kmack! Thank you for bringing this to our attention! I'm sure everyone is now going to run away from relief because you were so kind to notify us all of this horrific tragedy! We don't know what we would do without you... I wish I could send you money to compensate for all the value you bring to the table.
Ahhh... so you think they are funneling over $29 million to friends through the subcontracts and that's why they aren't finishing trials? Hmmm... interesting theory. I guess I never considered that. That doesn't seem fair. We should petition against it.
Are you upset because they haven't spent all the money yet?
Nope. The only $18 figure ever mentioned was seeking alphas article.
You got the job????!!!! That's awesome!!!... I totally wasn't expecting that!
Ahhh! I see now... you think its better to treat the patients by enrolling them in the trial, instead of just giving them the drug directly without a trial, that way they get the drug AND they also get monitored by the trial. Ok... that makes sense. That's actually a pretty good idea. That would make a better case against big pharma too. BP wouldn't be able to hold a candle against that strategy.
Ahhh... I found my misspelling in the email address. Resending this. I'll let everyone know if I hear back.
odfisherslane1@uc.nih.gov
Hi… I just finished watching your live board meeting… excellent and thank you! I do have a question…
There was much talk about moabs and vaccines, and I was wondering if any of the VIP drugs such as Aviptadil have shown any notable progress, and if so, could you please elaborate?