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Javitt’s most recent LinkedIn post:
Thank you Kyna for this wonderful handmade bowtie, in honor of what would have been Sami Said's 93rd birthday. I promise to wear it to the FDA meeting when we discuss our results #ZYESAMI #covid?19 .
https://www.linkedin.com/posts/jonathanjavitt_zyesami-covid%E3%83%BC19-activity-6780918203771035648-HKB1
According to the Investor Relations FAQ section on Relief’s own website:
“When do you expect FDA- approvals for either the intravenous or inhaled formulations?
We cannot speculate on the likelihood or timing of FDA approvals. Day 28 top-line results from the U.S. Phase 2b/3 trial with the IV formulation of RLF-100™ were announced in February 2021. We anticipate longer term day 60 data to follow in March...”
https://relieftherapeutics.com/investor-relations#
I do not think the hospitals are ‘dropping out’- perhaps it is because the hospitals are done ‘recruiting’
According to the ACER 3rd Quarter Report on Nov 2020: “Regarding our emetine program, several in vivo studies are currently being conducted to evaluate the drug's safety and its specific activity against SARS-CoV-2 in the Syrian Golden hamster and ferret models. Coupled with the drug's in vitro data and emetine's long history of use in humans for other indications, we should have a good understanding of this candidate's potential as a therapeutic against COVID-19 relatively soon”
“Upcoming Milestones:
Anticipate in vivo efficacy results from ongoing animal studies evaluating emetine's anti-viral activity against COVID-19 by the end of the fourth quarter 2020
Targeting IND submission and potential initiation of the planned Phase 2/3 trial evaluating emetine in high-risk COVID-19 outpatients in the first half of 2021, subject to ongoing discussions with the FDA and additional capital”
Hello ACER longs, I apologize if this has been asked and answered, but I came over with the RLFTF crew and I hope someone can clarify where ACER-2820 (emetine) currently stands. From what I am able to find, ACER-2820 is a broad spectrum antiviral candidate which has been through a preclinical study for the potential treatment of COVID19 patients via subcutaneous injection. Do we know the results of the preclinical trial and are there sufficient resources available to continue the study? I read about possible capital via BARDA but am unable to find additional information or current status. Thanks in advance!
I am confused by the last paragraph at the end of the article because I thought that we did not have to apply for EUA again...
“Javitt said on Monday that the last patient just finished 60 days of treatment, and that he expected to file for another EUA within a couple weeks. As part of the Tuesday announcement, he said they will file “should the above trends continue through day 60.””
Here is an interesting article that gives some insight into Covid19 mutant variants. One of the take home points is the fact that there are 2 key mutations: mutation (N501Y) known to help the virus bind more tightly to human cells and another mutation (E484K) known to help the virus evade antibody detection. Also, laboratory experiments have shown that some of those mutations help the virus bypass detection by antibodies. (Side note: the patient was treated with Regeneron monoclonal antibodies and researches saw evidence that the virus was developing resistance or escaping the antibodies)
https://www.npr.org/sections/goatsandsoda/2021/02/05/964447070/where-did-the-coronavirus-variants-come-from
Now take a look at this article which uses a molecular computational approach to study the binding site of Aviptadil on SARS-CoV-2 nsp16/nsp10 complex which is necessary for the effective translation of coronavirus RNA and which is also essential for preventing immune recognition.
“Inhibitory effects of aviptadil on the SARS-CoV-2 nsp10/ nsp16 protein complex”
https://www.researchsquare.com/article/rs-191980/v1
Nothing is known for certain but this definitely helps reinforce my confidence in Aviptadil. IMO / GLTA
Reality is an opportunity before it is a hindrance. I picked up more shares as well. GLTA
RLFTF
As a newer investor I started by using Y_finance
I invested in RLFTF at 0.03 and have averaged up since. Started off invested in Moderna but started looking into therapeutics when it became clear that the vaccine market would be crowded with multiple players. New to investing with a background in medicine and molecular biology - complete believer in the science and singular uniqueness of Aviptadil. I was a lurker on the boards until I finally created an account for the primary purpose of muting/ ignoring certain individuals.
The Aviptadil inhalation trial is huge news especially since the age group to be studied is 12-85 yrs old. Currently those under the age of 21 are not a priority for vaccination because they account for 0.08% of Covid19 related deaths in the US, yet those under 21 account for about 26% of the US population.
Children can get sick from the Covid19 virus and children can suffer longer term effects, like multi system inflammatory disease of children (MISC). Should additional studies demonstrate that a VIP inhaler administered at home is safe and effective for the pediatric population, we are looking at the key to returning to a normal life at the very least and very possibly a novel SOC for how viral respiratory infections are treated. Exciting times! IMO
Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure (COVID-AIV)
First posted: March 17, 2020
Update on Jan 29, 2021
Est Primary completion date: Jan 21, 2021
Est Study completion date: Feb 28, 2021
Free speech rights only matter in issues of State Action
ACER is up 11% on 1/3 of its usual daily volume. Someone connecting the dots or are we seeing the low float at play?
Interesting that RLFTF is down -6% today yet ACER is +6%
“THIS PEPTIDE THAT PRODUCED WAS NOT THE SAME AMINO ACID AS OURS...”
So what is the AA sequence of the peptide BA produced and what is the AA sequence of Aviptadil? And you have a source for your statement of course?
To me “...expected by Jan 28...” means that NeuroRx itself expects to receive the data on that date. It does not mean that any data will be shared with or released to the public in part or in whole on the date communicated.
I would think that whenever the news drops, the timing would be at the convenience of the US market since NeuroRx is running the trial and the FDA is also US based
Warrants : shares = (1:1)
Rights : shares = (10:1)
I believe powerwalker was referring to the ratio of warrants to rights in his/her personal portfolio
Boom!!! Thanks for the post!
Been waiting for this since June. It’s show time!
“Maple syrup urine disease affects an estimated 1 in 185,000 infants worldwide”
Which I believe comes out to be roughly 113 new cases annually
https://medlineplus.gov/genetics/condition/maple-syrup-urine-disease/
Relief will compete because Relief has one drug treating multiple conditions. Better to have one drug capable of treating 10 conditions instead of 10 drugs treating 10 conditions; save on R&D, safety testing, etc...
“...Further, in connection with entering into the Option Agreement, Relief will make a $4.0 million loan to Acer. The loan, which will be secured by a lien on all of Acer's assets, will bear interest at the rate of 6% per annum and will be due in one year.”
So if Acer defaults on the ‘loan’ then Relief will own all of Acer’s assets?
Just pulled the trigger and now I’m in RLFTF, BRPA trio, and now ACER. One play but so many different angles and opportunities. Let’s see where this rabbit hole takes us
Geneva, Switzerland, and Newton, MA, USA, January 25, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF,OTCQB: RLFTF)(“Relief”), a biopharmaceutical company with its lead compound RLF-100TM (aviptadil) in advanced clinical development to treat severe COVID-19 patients, and Acer Therapeutics Inc. (Nasdaq: ACER)(“Acer”), a pharmaceutical company focused on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced that the companies have signed an Option Agreement providing exclusivity for the right to negotiate a potential collaboration and license agreement for worldwide development and commercialization for ACER-001. ACER-001 (sodium phenylbutyrate) powder is a taste-masked, immediate release proprietary formulation in development for the treatment of urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD).
Is Relief looking to use ACER to list on the Nasdaq? Does this decrease the likelihood of a NeuroRx / Relief future merger? The two companies going their own ways but joined by Aviptadil profit sharing? Not sure what the endgame is here. Thoughts?
Geneva, Switzerland, and Newton, MA, USA, January 25, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF,OTCQB: RLFTF)(“Relief”), a biopharmaceutical company with its lead compound RLF-100TM (aviptadil) in advanced clinical development to treat severe COVID-19 patients, and Acer Therapeutics Inc. (Nasdaq: ACER)(“Acer”), a pharmaceutical company focused on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced that the companies have signed an Option Agreement providing exclusivity for the right to negotiate a potential collaboration and license agreement for worldwide development and commercialization for ACER-001. ACER-001 (sodium phenylbutyrate) powder is a taste-masked, immediate release proprietary formulation in development for the treatment of urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD).
Nasdaq: ACER. Hmmmm....??
Apparently it does
https://pubmed.ncbi.nlm.nih.gov/12732342/
Does VIP cross the blood brain barrier?
To piggyback back onto JB’s answer, a contributing factor to the undervalued appearance of BRPA warrants and rights is the fact that BRPA common shares are priced ‘high’ due to only 600,000 shares in free float. Supply and demand. Warrants and rights will catch up.
JB also mentioned in a previous post that the rights are where the action will be. Food for thought.
Vanilla, you are avoiding my question so I will ask you again. Do you have first hand knowledge of this “audio of conference” having listened to the presentation in its entirety for context or are you just reacting to hearsay?
To address your current concerns use common sense and Occam’s razor. Usually simply looking at the date of the PR you are citing will answer the majority of your concerns regarding inconsistent numbers. Your remaining concerns can be addressed by realizing that Relief and NeuroRx are separate entities. IMHO, GLTA, BOYB
Vanilla - what precisely is the source of your information? Did you read it as you claim now or did you listen to the audio as you asserted earlier?
Please provide a link to your source since you are undoubtedly citing what you “read” from the company and not just repeating hearsay. Thank you
Of course you have first hand knowledge of this “audio of conference” and you have listened to the presentation in its entirety for context or are you just reacting to hearsay?
More than 150, more than 200... it does not matter. The important info from this article is that in an EAP study of 150 we have a 75% survival rate for those who would otherwise have a 80% mortality rate! Now if you want to nit pick the numbers then you should first find out the date the interview was conducted (not article publication date). IMHO. GTLA
Thank you for your factual contributions JB. I have learned a lot from your posts and I appreciate the time you spend sharing your information. I have been invested since May and I hold a high average cost because of my FOMO tuition. Another thing I learned is that no amount of positive thinking or cursing will change the timeline or SP. Everything depends on supply and demand.
I invested in RLFTF because of VIP - in the ancient war against microorganisms mammals evolved VIP, a protein so perfect that it remains unchanged and is identical in humans and mice even today. The ‘inhibit viral replication, stop the cytokine storm, protect aveolar type II cells’,
etc. is just scratching the surface of VIP applications. Thanks to COVID-19, we are all presented with an unique investment opportunity because when will we ever be able to own a product with global demand? GLOBAL. I am not talking about “I want an iphone” demand but rather “I don’t want to die” demand.
It doesn’t matter what the FDA motives are. It is inevitable the data will be released and if the FDA drags its feet acting on data from a gold standard double blind RCT study then the rest of the world and the respective regulatory agencies are free to use the study to make their own decisions. The US is big but the rest of the world is bigger. RLFTF gets 50% of sales profits in US, Canada, and Israel/ 85% Europe/ 80% rest of the world. An effective drug which is an endogenously occurring peptide in humans so it is safe AND cheap to produce? Europe, China, India... Supply and demand. Good for Covid and beyond. IMHO. GLTA
Best,
TB
196 enrolled in the RCT may not equate to 196 having received treatment so ‘more than 300’ treated would be accurate perhaps?
https://www.cnbc.com/2020/12/14/coronavirus-relief-therapeutics-shares-have-soared-38000percent-in-2020.html
“... Selvaraju revealed that Relief Therapeutics and NeuroRx had been in contact with Operation Warp Speed and said if the drug successfully proves its efficacy in seriously ill patients following phase three randomized testing, the company expects to receive stockpiling orders on a similar scale to the likes of Gilead and Eli Lilly...”
Molecular biology degree from Facebook
Medical degree from Google
What can go wrong?
Hydrogen and stupidity...
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