Relief Therapeutics Holding AG (RLFTF)

[Joe Kaplan]

Penny, FWIW..here they are....and the responses on y@h00 make much better sense than a lot of this, imho, but these are the posts,
and its clear that significant facts are missing in this little rambling narrative, along with a view that is unfathomable to me, plus a question about the identity and motive of this author that takes such a strange tactic of taking on yahoo posters and posting so profusely on a public BB.



Jonathan Javitt 8 hours ago 11.28.2021
@IG This response contains no information that is not already published in SEC-regulated filings. If you read our public filings, read the Bevec patent, and read the NYS complaint, you will learn that ZYESAMI was never formulated under the Bevec patent in any way. The NYS complaint (not written by us) states that ZYESAMI was not formulated under the Bevec patent and complains about that. It's clearly documented in the public record. You simply need to read it.

As we have stated publicly in filings and elsewhere, ZYESAMI was formulated from the start according to Sami Said's method, which predated the existence of Mondo biotech. The formulation method was licensed by NRx from the Research Foundation of the State University of New York. You should read our S1 filings carefully to understand the reason behind that, all of which is disclosed to the public and reviewed by the SEC.

Now that the original RFSUNY formulation is manufacturable at commercial scale with shelf stability that continues to be extended. Some investors still want to believe that we used the Bevec formulation. However, we have disclosed in multiple legal filings that we never did so and RLF has complained that we did not use the Bevec formulation. We took those actions in order to protect the safety of patients. We are not aware of any successful clinical trial in which that formulation was used. However, if somebody knows of successful use of the Bevec formulation, please send the clinical trial number to our scientific affairs dept. I remain puzzled by repeated claims on the internet that we used the Bevec patent when the owners of that patent complain that we did not use it. If we were accused of using the patent, of course, I could not discuss it in public while the matter is in dispute. However, one thing on which we and the patent owner clearly agree is that we did not use the patent in formulating ZYESAMI, RLF-100, or any other form of aviptadil.

PS: If you have been told that somebody bought the ARDS ODD from SUNY, you should ask to see the license agreement.



Jonathan Javitt 16 hours ago 11.28.2021
@Dan Of course nobody is making decisions based on 11 patients. However, when you are analyzing neutralizing antibodies and the data dispersion is as tight as was shown in the preprint, enormous sample sizes are not needed either. The estimated enrollment for BriLife Phase 2a is over 1000. See https://www.clinicaltrials.gov/ct2/show/NCT04608305?term=IIBR-100&draw=2&rank=2
The Data Safety Monitoring Board is scheduled to review the data this week as we have previously announced. The early data published by IIBR was an early sample designed to check immune response (serogenicity) early in the phase 2 trial.
Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine - Full Text View.
Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine - Full Text View.
www.clinicaltrial.gov



Jonathan Javitt 14 hours ago 11.28.2021
@Rinaldo Our public filings have been clear from the outset that the formulation used in our clinical trials is based on the formulation developed by Prof. Sami Said and used in NCT 05311697. No change was made in formulation during any clinical trial. However, that formulation began with only a few weeks of stability, as was reported in our public filings. Remember that Dr. Said formulated aviptadil in a hospital pharmacy from nonsterile ingredients and used the material immediately in his clinical trial (NCT 00004494). The IND and work papers are licensed to NRx by the Research Foundation of the State University of New York. The sterilization procedure and release protocol used at the time is no longer used in the US today.

Prior to our involvement (as described in our filings and conference calls) we are unaware of a manufactured commercial-scale, shelf-stable, GMP product from this formulation. We are well aware of what the FDA does and does not allow, based on our close contact with the FDA and having successfully completed a review of module 3 of IND 149,152. You should also note from our web page and public filings that our manufacturing is led by people who have held senior manufacturing and R&D roles at some of the world's largest pharmaceutical companies. If you have manufacturing expertise to contribute that could help speed this medicine to patients, you are welcome to submit your credentials to us. Others have tried in the past to achieve a clinically-effective, shelf-stable commercially-manufactured version of aviptadil without much success. We have reported success in that regard in our filings and conference calls. If we could have achieved that milestone one day sooner, we certainly would have done so. Nobody would continue to support clinical trials with small-batch handmade investigational product if a proven commercial-scale manufacturing process was available and reviewed by regulatory authorities.

The issues related to EUA relate to demonstrating safety and efficacy, as we have advised investors. The short shelf life of the hand-made material certainly created supply-chain challenges for us, but we were able to support multiple clinical trials as well as expanded access and right to try requests. To the best of our knowledge, no company in history has taken a medicine in 10 weeks from dormant files to an investigational product allowed by FDA for clinical trials use in patients. FDA, of course, was well aware of the short shelf-life of our early investigational product and was aware of our program to extend that shelf life, as were our investors. At the time we launched the program, we had fewer than six employees. Within 10 months of that cold start, we delivered data from the first clinical trial and were selected from a field of 600 candidate drugs (according to Dr. Francis Collins) for an NIH-funded global phase 3 trial. All of that was accomplished with less than $25 million in total R&D spend as reported in our public 3rd quarter financials. You may wish to consult various industry sources to form an opinion as to whether that was a large or small amount by the standards of drug development.

We will continue to present additional information on safety, efficacy, and manufacturing to regulators around the world as such information becomes available in support of EUA, Accelerated Approval, and final New Drug Approval, as we said in our conference call. Thank you for following our progress.

Your allegation that people have died because our team has underperformed is as despicable as it is libelous



Jonathan Javitt 13 hours ago 11.28.2021
@barry If you are aware of clinical trials of intravenous aviptadil previously performed by the entities you name, you might want to share that information with the public together with clinical trial numbers and relevant publications. Certainly, the data from such trials, if they exist, would be important for regulators to consider today. The formulation used in our clinical trials is based on Prof. Said's formulation that worked successfully twenty years ago and that the FDA accepted for both our clinical trials and the NIH trials. Dr, Youssef just published the work that he and Dr. Said did together. That is the formulation (though not the manufacturing method) that has been used since we began this project. You don't seem to understand that RLF-100 was a trademark I invented and filed at the outset of the project. The mark was rejected by the US Patent and Trademark office because of its similarity to other, unrelated trademarks. You can read the history on www.uspto.gov. In the collaboration agreement, we agreed to leave that name for RLF to use outside the US. Prior to our initiation of this project, the name RLF-100 did not exist. The USPTO has now granted us registration of ZYESAMI, which will be the mark going forward.

If you think some other formulation of aviptadil for ZYESAMI should be used, you are welcome to submit scientific data to us or to the public in support of that formulation. If you believe there are prior clinical trials of which we should be aware, please tell us.

Obviously, we are not going to discuss an agreement that is currently in mediation, but you are welcome to read our 8K.


Jonathan Javitt 18 hours ago 11.28.2021
@Mar. as disclosed in the public filings of NRXP, the prior art on which ZYESAMI is based is owned by the Research Foundation of the State University of New York and has been owned since before 2000. You may read our license to that prior art in our public filings. The entities to which you refer have never shared any information with NRXP.