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Where are you looking... I'd rather be looking there LOLOL
GM everyone... I'm also showing Swiss up only 0.35%... but I'm on 15 min delay.
welcome ;)
Have a good night everyone!
I'd be up for that.
Thanks aGuy! I included it in the summary:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=158658045
You're welcome
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. I’ve compiled an accurate summary of key DD (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:
I would think... whether the patient is on the drug or part of the placebo, the end point could come sooner if the patient dies or drastically improves, but... the 28 days +review time and reporting time are a good measure of timeline... otherwise we end up back in the same situation of incorrect assumptions that occurred yesterday, resulting in a selloff from missed expectations. Let's all work to keep expectations in line.
It is true that trial enrolments are running slower than I anticipated. Doesn't change this drug's potential.
Doesn't impact EUA application, unless fda says they need more data to show that the drug "may be effective".
Oh... sorry 123456714... forgot to take you off the list now that you're with us.
No... he is slammed. CEO launching the drug of the century... I was surprised to hear he was even attempting to carve out time for Dr Yo.
I think all the newbies are slowly digesting what's happening here. They first get sucked in with hype, then they start to realize. There's more cash in those newbies pockets, and it will come out over time as they wrap their minds around this.
Try this... imagine the chart... what will it look like in 3+ months from now? Our current chart is just a blip on that much larger 3-month future chart... that's exactly what we are supposed to look like... a couple little blips with some increase in SP along the way before it goes up to double-digit-dollars. In 3 months, new investors will be coming in and looking at our blip, thinking "gee I wish I knew back then... must be insiders who knew back then... lucky bastards". And in my head, I'll be responding to their thoughts with "geez... if you only knew how many people were complaining back then."
Just the EUA in and of itself isn't what's going to launch us... its also the media reach EUA will bring. We obviously need more investors than the limited few that have been in since Aug (and the newbies from the past couple weeks). Once EUA hits, mainstream media will pick it up... and at that point, as TradeMax says... its gonna get nutsy!
You are the strangest batch of numbers I've ever seen.
If I had 500,000 shares purchased at .04c, and good news like this came out, I would be inclined to take a little profit. This is the case for many of the Swiss. We are buying their shares, and the same thing will happen for us when the rest of the world finds out. Patience my friend. We'll get our Hammer Time ;)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=158612753
Some things I'm excited about...
- Enough immediate production capacity to meet US stockpile needs will raise revenue estimates... and that's just US stockpile. There's still the rest of the world that will be banging on our door for supply.
- I am 99.99% confident we will obtain EUA approval and FDA approval on both the IV and the inhaler.
- I am 99.99% confident Aviptadil will have other significant applications.
- I am 99.99% confident we will hit mainstream media within October.
- The IV for covid, the inhaler for treating mild to severe covid, the inhaler for preventative treatment of covid, Aviptadil for other lung issues, Aviptadil for other biological issues... this is a very serious long-term play.
- I am 99% confident we get a Nasdaq uplisting or buyout of $50B+ (likely both)
You and I bought this thing for under 65c... who knew an OTC penny would have real potential like this.
Well... this morning's news certainly indicates we are ready for BARDA-level supply. We now have 2 manufacturers, and Bachem alone is contracted to do 1 million patients. Plus overnight delivery... this will roll out quick!
I'm in tune with that rap...
see a late day run, a dr yo momo fomo
Yes sir!
This is why I think we haven't had an announcement yet (been kept quiet). Once the cat is out the bag, the world will know, and the US will need to protect its interest in stockpile... heavy worldwide demand will be at their door, orders, manufacturing, distribution all under pressure... you have to be really really ready to let that cat out the bag. Relief & Neuro better have their running shoes on!
It will be promoted heavily tomorrow morning by the yahoos and twitts... there will be plenty of retail investors tuning in and learning plenty of new info. Yes... if he mentions BARDA... that should send them into a light frenzy.
Dr. Yo w Dr. Javitt
Tomorrow morning live... here's the link:
Regarding...
I don't believe Javitt would have applied for an EUA at this time if he didn't feel his chances were at least greater than 50%.
If we don't break through 62 today, the Yo JJ interview should do it.
Question for the forum...
In that video, at marker 4:42, Congressman Harris says the following in regards to VACCINES:
“I’m pretty confident, looking at the preliminary data from the 3 phase III trials already, that it’s very possible that by the October 22nd FDA meeting, that they grant Emergency Use Authorization to 1 or 2 candidates…” (referring to vaccines)
Does the FDA only grant EUA's at their meetings? Are we looking at October 22 as well?
I call it the "penicillin of the lungs"... the drug of the century.
I see. There is always a possibility of a buyout as well, so keep that in mind too.
EUA is for IV.
One inhaler trial is for the treatment inhaler (US trial), and the other is for the preventative inhaler (Europe trial).
Potential campaign strategy?
- Announce new testing
- Announce new therapeutics
- Announce new vaccines
- Announce US re-opening
fly on wall is a fraud... they deliberately post misleading news as a joke.
wow look at all those 1,000 share buys going through
In addition to the title, here's my favorite line from the article:
"For all these reasons, we believe RLFTF is a must-own."
https://insiderfinancial.com/rlftf-is-tremendously-undervalued/180443/