If you go to rumble. com and search for Mark Levin, do you see the video there???

I’m going to go out on a limb a little here by saying I expect we will receive an answer to the question of the EUA between now, and the end of November at the very latest. Why?

Well, if Aviptadil TRULY has a shot at Breakthrough Designation…and personally, I really think it does based on the Science, not personal feelings…the answer regarding the Breakthrough Application must be rendered by 04 December 2021, as per FDA Policy. (The Policy states a determination will be rendered within 60-days of receipt of the application. **See #22 of the FDA’s Q&A Section of their internet site related to Breakthrough Designations.)

So, as long as Neuro did in fact file the Breakthrough Designation Application on 04 October 2021, as we were all told it was, then how much sense would it make to withhold the EUA determination, only to provide a potential affirmation of Breakthrough status?

I know…the going out on a limb bit is definitely “that” since I’m using the assumption that Breakthrough Designation is highly probable. But based upon the evidence…it truly IS probable.

Time will bear it all out though.
—Cheers—

~ Brian A, Y@h00 RLFTF finance conversations

NRXP/Javitt succeeded where Mondo Biotech failed. NRXP reached agreement with SUNY and obtained license to continue development of Zyesami. How much of their 50% (collaboration with RLFTF) did NRXP agreed to share with SUNY in the event the FDA grants EUA and eventually approval??? What government agencies are involved in the development of ZYESAMI??? In the event ZYESAMI is granted EUA/approval, what will it take to make RLF-100 an equivalent to Zyesami (TM)??? First and foremost, I want NRXP to get EUA from the FDA!

A drug product is deemed to be therapeutically equivalent ("A" rated) only if: a drug company's approved application contains adequate scientific evidence establishing through in vivo and/or in vitro studies the bioequivalence of the product to a selected reference listed drug.

https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-glossary-terms

My opinion: if RLFTF is to get anything/opportunities out of AVIPTADIL development, NRXP must be successful in getting EUA.

Do you concur???

The FDA rejected the use of 52,088 on the grounds that the IND was an investigator-sponsored IND owned by Stony Brook University and canceled by FDA in 2014 after the death of the IND Principal Investigator, Professor Said). No other IND for aviptadil was in force in any jurisdiction and it was learned that the predecessor of Relief Therapeutics had applied for and not been granted an IND for human use of aviptadil on multiple other occasions.

With the agreement of Relief Therapeutics, NeuroRx submitted an FDA compliant IND 149,152 to FDA on March 24, 2020 and was issued a “Study May Proceed” letter by FDA on March 28, 2020.
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In addition, in September 2021, NeuroRx and Relief Therapeutics agreed to collaborate as separate companies under a structure where Relief Therapeutics had the right to fund all development costs related to aviptadil for respiratory diseases in exchange for a predetermined division of profits and NeuroRx had the right to continue its development program with other investor funds should Relief Therapeutics not provide funding. The agreement recognizes ownership by NRx of all intellectual property developed by or licensed by NRx with Relief Therapeutics advised its investors in various annual reports issued in 2020 and earlier that it had formulated aviptadil as a human drug and had “1 million doses” available to treat patients. In the course of development, NeuroRx learned that there was no stable formulation of aviptadil and began developing the intravenous formulation with manufacturing records submitted to and reviewed by FDA.

We reported to Relief Therapeutics in December 2020 that the formulation data provided by Relief Therapeutics could not be replicated and that a new formulation and manufacturing method was required. Moreover, we were warned by a former Relief Therapeutics declined to fund the costs of developing a stable formulation of aviptadil, which NRx proceeded to do with funding from other investors under the tradename ZYESAMI, named for Professor Sami Said. In May 2021, Relief Therapeutics advised its shareholders that Relief Therapeutics was aware of the stability problems with its formulation at the time it signed the September 2020 collaboration agreement.

ZYESAMI is not currently covered by any US or international patent. US Patent 8178489B2 and foreign counterparts does not apply to ZYESAMI because it covers only formulations of aviptadil that are formulated in a buffer. Laboratory evidence suggests that VIP (aviptadil) aggregates and may be inactivated by known buffers. We are engaged in a discovery process to extend the stability of ZYESAMI and has made certain discoveries that may lead to future patent filings and which may or may not lead to allowed patent claims. In the event that no patent protection is granted covering the formulation of ZYESAMI, if the drug is approved by FDA, it is anticipated to receive at least five (5) years of data exclusivity from the FDA under what is commonly known as “paragraph 4” protections. Should no patents be granted by the end of this data exclusivity period, competitors may be able to market generic versions of ZYESAMI.

https://content.equisolve.net/sec/0000950142-21-002866/eh210183152_ex9901.htm

I have read and re-read the C.A several times, and I continue to walk away with different “impressions” that re-shape my thoughts about it. Again, we do not know the contents of the N.D.A. nor the Development Agreement.

However, based on the strict reading of the language of the C.A., my OPINION is that this Agreement is very much Executory in it’s terms. You can look up what an Executory Contract means. Long and short, it means a contract that is unperformed and one where the parties have continuing obligations to each other. The obligations remain for both NRXP and Relief.

~ Bogo, Y@h00 RLFTF finance conversations

…E. “Dr. Javitt Seeks to Capitalize on Aviptadil's Early Success by Demanding that Relief Renegotiate the Terms of their Collaboration while Simultaneously Attempting to Circumvent Relief through a Secret Agreement with SUNY Stony Brook”
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.
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From the CA:
“Relief assets to be utilized in the Collaboration include:
US and European Union Orphan Drug Designations Related to ARDS”….

And yet from the 9/15/2021 NRXP prospectus page 102:

“Moreover, the FDA awarded Orphan Drug Status to the State University of New York at Stony Brook for the use of RLF-100, a prior formulation of ZYESAMI, in ARDS in 2001.”

~Raven, Y@h00 RLFTF finance conversations

A certification that the proposed product will not infringe the already approved product’s listed patents or that such patents are invalid or unenforceable is called a Paragraph IV certification. We may seek Paragraph IV Certification for our product candidates. If the applicant does not challenge the listed patents or does not indicate that it is not seeking approval of a patented method of use, the ANDA or 505(b)(2) NDA application will not be approved until all the listed patents claiming the referenced product have expired.

If the ANDA or 505(b)(2) NDA applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and patent holders once the application has been accepted for filing by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days after the receipt of notice of the Paragraph IV certification automatically prevents the FDA from approving the ANDA or 505(b)(2) NDA until the earlier of 30 months, expiration of the patent, settlement of the lawsuit, a decision in the infringement case that is favorable to the ANDA applicant or other period determined by a court.

https://www.sec.gov/Archives/edgar/data/1719406/000119312521208673/d175615ds1a.htm

It does help answer questions, apprehensions, some SH like myself may have. Thx

This is a continuation of my post from this morning. Having read the C.A, I do have an impression of it.

Before I state it, please understand that we as Attorneys make argument to the Trier of Fact. We render opinions based on precedent, i.e., Primary authority - case law, statutory authority, and Secondary authority - Treatises and other learned opinions, that are relevant and supportive of our arguments.

I have read and re-read the C.A several times, and I continue to walk away with different “impressions” that re-shape my thoughts about it. Again, we do not know the contents of the N.D.A. nor the Development Agreement.

However, based on the strict reading of the language of the C.A., my OPINION is that this Agreement is very much Executory in it’s terms. You can look up what an Executory Contract means. Long and short, it means a contract that is unperformed and one where the parties have continuing obligations to each other. The obligations remain for both NRXP and Relief.

Therefore in my opinion, there is a reason to keep the communications flowing, and I believe the Companies know that this MUST occur.

The Agreement in at least 2 places refers to an “Arbitrator” being appointed to render a decision on disagreements. And, as stated in my earlier post, there is no Breach Clause or definition of what a “material breach” is relative to the duties of the parties. In my opinion, you can glean the parties intent from a Breach clause not existing and from continuing obligations existing.

My impression is, that the Companies never intended for a non-performance to create a cessation to their obligations. Non-performance can be different from a breach. Rather, the C.A, speaks in terms of “if a party does not do X, then the opposing party does not have to do Y, or the opposing party can do Y.” But it never says, that the contract is ended and the obligations of the parties cease.

Therefore, the disagreement here is an isolated issue. Only drawing from facts that have been posted, it appears to be isolated to whether NRXP can hold back data and invoices and Relief not issue funds commensurate with the Agreement, and if that occurred, whether NRXP can proceed without Relief. But the agreement still creates obligation upon NRXP to Relief, even assuming that occurred. As to what came first, we have the proverbial “chicken vs. egg” scenario.

I believe NRXP knows they have a continuing duty pursuant to this Agreement. That is well certain. The issue is quite simple - “as long as Relief funds the research and development costs for developing such use,” Definition “Product”, and “NeuroRx is responsible for ensuring that all activities undertaken under the Project (a) comply with the Development Plan, (b) do not exceed 30% of the budget contemplated by Relief’s Board of Directors on March 22, 2020,” Section 4.4, and also consideration of Section 8.1

As the for the argument that NRXP thought it was receiving a stable substance, the “Stability argument,” there are many inferences in the C.A., and direct language in the IP itself, that clearly speak to a formulation or several formulations that need to occur, and stability being an issue. Keenly on point, Section 8.2 : “Relief shall fund the costs of formulation and stability of the Product at MediSourceRx and Bachem, together with technology transfer to Nephron Pharmaceuticals or other mutually agreeable commercial manufacturers.” This reference is clearly future looking, and the development of the “product” is the purpose of the C.A., so “stability” was a future contemplated occurrence.

~ Bogo, Y@h00 RLFTF finance conversations

REPLIES…

After reading the CA several times myself, I conclude that I shall remain ……a farmer : when I milk my cows, I get…milk…not beer, not jelly beans and definitely not possibly some Cold Turkey….
Law is definitely for sharp people.
Thank you for shedding some light on this issue. I feel I am on the good side here.

~ John, Y@h00 RLFTF finance conversations

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As crazy as it seems I still have a strong opinion that this crossroads is as much about strengthening IP ownership of the drug as a Global Concern, as much as it is Ram and Javitt squabbling over where the fine line should be drawn in the sand with regards to the product and revenues, before they begin to roll in next year.

~ WolfZen, Y@h00 RLFTF finance conversations

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@WolfZen Interesting “Product” is defined as including both intravenous and inhaled. Additionally, Paragraph 12.5 of the C.A. addresses further funding by Relief for the inhaled version.

~ Bogo, Y@h00 RLFTF finance conversations

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@John Laughing. I am humbled and I am always mindful that I cannot farm, milk cows, nor care for a cow. You have expertise that I don’t. Thank you for all the milk! My children love it.

~ Bogo, Y@h00 RLFTF finance conversations

——————->

@rant_and_roll The C.A. provides different obligations upon the parties for the intravenous vs. the inhaled, despite the fact that the “product” being developed is both.

~ Bogo, Y@h00 RLFTF finance conversations

==================================

NeuroRx is a clinical-stage small molecule pharmaceutical company which develops novel therapeutics for the treatment of central nervous system disorders and life-threatening pulmonary diseases. On September 21, 2020, NeuroRx announced a commercial partnership with Relief Therapeutics Holding AG for global commercialization of RLF-100 (aviptadil acetate) (now reformulated as ZYESAMITM), an FDA Fast Track-designated, investigational, precommercial drug for COVID-19 related respiratory failure (the “NeuroRx COVID-19 Drug”). This product candidate has not yet been submitted for approval and has not yet been approved by the U.S. Food and Drug Administration (“FDA”). The partnership affords Relief Therapeutics the right to fund all formulations and clinical development of aviptadil for treatment of respiratory disease, in exchange for a predetermined share of profits. See the section titled “Business of NeuroRx — Summary of NeuroRx Material In-licensing Obligations — Aviptadil/ZYESAMI — Binding Collaboration Agreement with Relief Therapeutics — Division of Profits” for more information.

https://seekingalpha.com/filing/5543540

Wow! This is crazy if confirmed! NRX just filed an 8-K discussing a separate agreement being formed for the Brilife vaccine and conducting trials in Georgia. Is it a blatant lie by JJ? If so and Georgia and the state of Israel refute the deal/terms then game over!

~ NY-Anthony, Y@h00 RLFTF finance conversations

It is great news that RLF-100/RLFTF is NOT in any way involved in gain-of-function-research

https://nypost.com/2021/10/21/nih-admits-us-funded-gain-of-function-in-wuhan-despite-faucis-repeated-denials/

The Ministry of Health denies the information spread by the pharmaceutical company NRx and the Institute of Biological Research of Israel that tests of the COVID vaccine created in Israel are planned in Georgia. The Minister of Health Ekaterine Tikaradze said on "Rustavi 2" that the relevant agencies will be interested in why such false information is spread.

https://bm.ge/ka/article/the-group-of-friends-of-georgia-express-their-support-for-georgias-sovereignty/89129

Bogo’s “keen legal analysis” had an analgesic effect in me.

Have you read anything about this??——— Georgia is not going to participate in the vaccine trial "- Tikaradze accuses the company of lying to NRX

https://bm.ge/ka/article/the-group-of-friends-of-georgia-express-their-support-for-georgias-sovereignty/89129

JJ caught lying again. Dude is slimy.

The Ministry of Health denies the information spread by the pharmaceutical company NRx and the Institute of Biological Research of Israel that tests of the COVID vaccine created in Israel are planned in Georgia. The Minister of Health Ekaterine Tikaradze said on "Rustavi 2" that the relevant agencies would be interested in why such false information is spread.

"This is misinformation. No meeting has been held with this group at the Ministry of Health and Georgia is not going to participate in such an attempt, as Georgia now has access to experienced and world-renowned vaccines and has direct communication and contracts with the manufacturers of these vaccines. It is important for us to vaccinate the population with safe and already tested vaccines.

I can not conclude why such information is spread. I am sure that the relevant services will be interested and there will be a response as to why the company is disseminating this information, ”said Ekaterine Tikaradze

~ Wong, Y@h00 RLFTF finance conversations

Go to Y@h00 finance for RLFTF and select “conversations”.

Here is more “keen legal analysis” from Bogo!

This is a continuation of my post from this morning. Having read the C.A, I do have an impression of it.

Before I state it, please understand that we as Attorneys make argument to the Trier of Fact. We render opinions based on precedent, i.e., Primary authority - case law, statutory authority, and Secondary authority - Treatises and other learned opinions, that are relevant and supportive of our arguments.

I have read and re-read the C.A several times, and I continue to walk away with different “impressions” that re-shape my thoughts about it. Again, we do not know the contents of the N.D.A. nor the Development Agreement.

However, based on the strict reading of the language of the C.A., my OPINION is that this Agreement is very much Executory in it’s terms. You can look up what an Executory Contract means. Long and short, it means a contract that is unperformed and one where the parties have continuing obligations to each other. The obligations remain for both NRXP and Relief.

Therefore in my opinion, there is a reason to keep the communications flowing, and I believe the Companies know that this MUST occur.

The Agreement in at least 2 places refers to an “Arbitrator” being appointed to render a decision on disagreements. And, as stated in my earlier post, there is no Breach Clause or definition of what a “material breach” is relative to the duties of the parties. In my opinion, you can glean the parties intent from a Breach clause not existing and from continuing obligations existing.

My impression is, that the Companies never intended for a non-performance to create a cessation to their obligations. Non-performance can be different from a breach. Rather, the C.A, speaks in terms of “if a party does not do X, then the opposing party does not have to do Y, or the opposing party can do Y.” But it never says, that the contract is ended and the obligations of the parties cease.

Therefore, the disagreement here is an isolated issue. Only drawing from facts that have been posted, it appears to be isolated to whether NRXP can hold back data and invoices and Relief not issue funds commensurate with the Agreement, and if that occurred, whether NRXP can proceed without Relief. But the agreement still creates obligation upon NRXP to Relief, even assuming that occurred. As to what came first, we have the proverbial “chicken vs. egg” scenario.

I believe NRXP knows they have a continuing duty pursuant to this Agreement. That is well certain. The issue is quite simple - “as long as Relief funds the research and development costs for developing such use,” Definition “Product”, and “NeuroRx is responsible for ensuring that all activities undertaken under the Project (a) comply with the Development Plan, (b) do not exceed 30% of the budget contemplated by Relief’s Board of Directors on March 22, 2020,” Section 4.4, and also consideration of Section 8.1

As the for the argument that NRXP thought it was receiving a stable substance, the “Stability argument,” there are many inferences in the C.A., and direct language in the IP itself, that clearly speak to a formulation or several formulations that need to occur, and stability being an issue. Keenly on point, Section 8.2 : “Relief shall fund the costs of formulation and stability of the Product at MediSourceRx and Bachem, together with technology transfer to Nephron Pharmaceuticals or other mutually agreeable commercial manufacturers.” This reference is clearly future looking, and the development of the “product” is the purpose of the C.A., so “stability” was a future contemplated occurrence.

~Bogo, Y@h00 RLFTF finance conversations

My post gives credit to ~ Bogo, Y@h00 RLFTF finance conversations, for the keen legal analysis. Thx

My post gives credit to ~ Bogo, Y@h00 RLFTF finance conversations, for the keen legal analysis. Thx

Ladies and Gentlemen, … I have been here for quite a long time - far beyond a year. I own stock in both companies and will continue to hold.

I have been Litigation Attorney for 30 years, State and Federal.

I have read the Civil Complaint, and have seen/read statements “attributed” to JJ and also spoken by JJ. I have observed actions of both companies through the development process.

The Collaboration Agreement (C.A.) is quite an interesting agreement. A Non-Disclosure Agreement (N.D.A.) between the parties and signed September 9, 2020, is incorporated by reference to the terms of the C.A., as is a written Development Plan, (D.P.) “mutually agreed by the parties.”

These will prove to be most interesting to the parties INTENT. In a Contract dispute, INTENT of the parties, is what a Court will seek to answer. The C.A., is a piece of evidence toward understanding that.

And, because of the current posture of the E.U.A., coupled with the need to protect the investors of both companies, Declaratory Relief will, …. or should, be sought immediately. Parties can be enjoined from performing certain activity, or activity can be ordered to occur. The investors in a public company will be heavy consideration factored in by the Court.

Interestingly, the C.A., does not define what actions would constitute a “breach” or “material breach” by either party. A material breach “might” allow JJ to assert what he has, i.e., “they failed to pay, so I did XYZ.” However, equitable claims exist, promissory estoppel and unjust enrichment by Relief. Further, it is Relief’s IP.

Now, looking at the Exclusivity Paragraphs 5.1-5.4 of the C.A., is defining. The C.A. was for the development of a COVID-19 “product,” or ailments “reasonably related.” And, it delegated responsibilities accordingly. Paragraphs 5.3 and 5.4, define the parties conduct for non-COVID-19 treatments, should either seek to develop them. Obviously, the Trials we have been watching are COVID-19 related.

So, the good news, expect Declaratory motion practice very early in the litigation, and I would say immediately so to preserve, protect and pronounce the parties actions while litigation is occurring. I wouldn’t discount, at any time, that the parties reach agreement. It certainly is in their interest. Legal fees are expensive particularly for budding companies.

Asking me my opinion as to who did what? As an astute poster stated: “we don’t know the facts.”

But, we are here and our interests need to be protected.

Safety and efficacy of the science appears beyond where we are now. Now, it is checking the boxes of manufacturing, distribution and getting past the FDA’s need to pump vaccines, and not allow people to believe that “another method of treating CVD19” exists. That is my opinion.

Long and strong

~ Bogo, Y@h00 RLFTF finance conversations

Replies ——————————————

I say : You made my day ! How wonderful it is to have on- hands experts on this Board !

I figure the Judge in New York won’t allow NRx to destroy Relief whilst the litigation is going on…meaning the $ flow will have to be shared once the Fat Drug Administration sings its tune…

~ John, Y@h00 RLFTF finance conversations

————>

@John Correct

~ Bogo, Y@h00 RLFTF finance conversations

2- In the Registration Statement, NRx accuses Relief of misleading them and Relief's public shareholders about the stability of the formulation of aviptadil that Relief brought to the parties' collaboration. Relief reiterates, once again, that in its opinion, there is no truth to these allegations, and that NeuroRx was expressly tasked with developing a stable formulation of aviptadil under the Collaboration Agreement. Further, Relief reiterates, once again, that it never guaranteed that it already had an 18-month shelf stable product, and no such statements are made in the Collaboration Agreement, which contains the entire agreement between the parties. Finally, Relief once again reiterates its belief that the version of aviptadil that was and is being used by NeuroRx in its clinical trials is the drug version covered by the Collaboration Agreement.

https://relieftherapeutics.com/newsblog/relief-therapeutics-comments-on-certain-statements-made-by-nrx-pharmaceuticals-in-its-registration-statement-on-form-s-1-filed-on-september-3-2021

This is some good reference material pertaining to the RLFTF vs. NRXP collusion collision.

https://relieftherapeutics.com/newsblog/relief-therapeutics-comments-on-certain-statements-made-by-nrx-pharmaceuticals-in-its-registration-statement-on-form-s-1-filed-on-september-3-2021

~ GeraldS, Y@h00 RLFTF finance conversations

The global market value was $9,4 bn in 2015 and it is expected to reach $13,1 bn in 2022, with a compound annual growth rate (CAGR) of 4,7 %1. Among the leading categories of advanced wound care, wound cleansers are expected to attain $2,1bn in 2023, growing at a CAGR of 5,4%1 from 2016 to 2023.

https://www.apr.ch/apr-pharma-products/therapeutic-pharma/wound-management/

AdViTA COULD HAVE SIGNED A COLLABORATION AGREEMENT, HAVE RELIEF FUND THEM AND THEN INFRINGE ON THEIR PATENT, NO???

In April, Relief and AdVita initiated an investigator-sponsored phase 2 trial with inhaled aviptadil for the prevention of Covid-related acute respiratory distress syndrome. The study, “Inhaled aviptadil for the Prevention of Covid-19 Related ARDS” (NCT 04536350), is a randomised, double-blind, placebo-controlled phase 2 trial being conducted at major clinical sites in Switzerland.

http://www.privateequitywire.co.uk/2021/07/28/304200/relief-acquire-all-outstanding-shares-advita

LETS HELP OURSELVES WITH SOMEONE ELSES PROPERTY, A RECIPE FOR POVERTY…???

ARE VACCINES AND GOVERNMENT PUSHERS AT FAULT???

Respected virologist Dr. Bill Gallaher, Ph.D., made excellent arguments as to why you would expect cross reaction. Due to beta sheet conformation similarities between spike proteins and syncytin-1 and syncytin-2.

I have yet to see a single immunological study which disproves this. Despite the fact that it would literally take the manufacturers a single day to do these syncytin studies to ascertain this [once they had serum from vaccinated individuals]. It’s been over a year since the assertions were first made that this [the body attacking its own syncytin proteins due to similarity in spike protein structure] could occur.

We have seen 100 pregnancy losses reported in VAERS as of April 9th. And there have [also] been reports of impaired spermatogenesis and placental findings from both the natural infection, vaccinated, and syncytin knockout animal models that have similar placental pathology, implicating a syncytin-mediated role in these outcomes.

Additionally, we have heard of multiple reports of menses irregularities in those vaccinated. These must be investigated.

We simply cannot put these [vaccines] in our children who are at .002% risk for Covid mortality, if infected, or any more of the child-bearing age population without thoroughly investigating this matter.

https://www.informedchoiceaustralia.com/post/uncensored-dr-janci-chunn-lindsay-ph-d-molecular-biologist-and-toxicologist

Chronic wounds represented a global expenditure of $143 bn.

RELIEF THERAPEUTICS REPORTS TWO PUBLICATIONS OF POSITIVE DATA ON NEXODYN® AOS FOR HARD-TO-HEAL ULCERS

https://relieftherapeutics.com/newsblog/relief-therapeutics-reports-two-publications-of-positive-data-on-nexodyn-aos-for-hard-to-heal-ulcers

~ Franz, Y@h00 RLFTF finance conversations

Reply ——————————————

Be careful now ! JJ might call it Zyexodyn !

~ John, Y@h00 RLFTF finance conversations

So I thought the IQVIA announcement in September was a new partnership. The Feb BRPA SEC filing indicates otherwise:

“We note your statement that you generated financial projections in partnership with
IQVIA that estimate potential gross sales in excess of $1.4 billion for the treatment of COVID-19 in the United States. Please revise to disclose the time period over which these gross sales are projected to be realized. Please also provide the consent of IQVIA in accordance with Rule 436.”
$NRXP $RLFTF

https://www.sec.gov/Archives/edgar/data/1719406/000000000021002365/filename1.pdf

https://www.iqvia.com/en/newsroom/2021/09/iqvia-and-nrx-pharmaceuticals-collaborate-on-potential-medical-support-for-novel-covid-19-treatment

~ Rick, Y@h00 RLFTF finance conversations

PER THE CDC…

The CDC defines a vaccine4 as a a suspension of live or inactivated microorganisms, such as viruses or bacteria, or fractions of these microorganisms, which are administered to induce immunity and prevent infectious diseases. A vaccine stimulates a person’s immune system to produce immunity to a specific infecting organism, or pathogen, that can cause a disease. If you are immune to an infectious disease, then you can be exposed to the pathogen without becoming infected, and you cannot transmit the infecting organism.

https://www.hotzehwc.com/wp-content/uploads/2021/05/Hotze-vaccine-ebook-rev-5-May-2021.pdf

WHO IS PUSHING THEM JABS???

https://www.instagram.com/p/CVMLzCQJxAr/?utm_source=ig_web_copy_link

So the active ingredient is “Rlf-100”…

https://www.sec.gov/Archives/edgar/data/1719406/000119312521118931/d56937dex1041.htm?fbclid=IwAR11lJ0oa1E8aZwpX1gVRugC_hccZKfD_PPYvjWhPwfgGIFWmBb_KT7ZdOU

~ Baxter Crewz, Y@h00 RLFTF finance conversations

Replies ————————————

https://www.sec.gov/Archives/edgar/data/1719406/000000000021002365/filename1.pdf

Business of NeuroRX, page 173

14. We note your references throughout to ZYESAMI, RLF-100, VIP and aviptadil. Based on the disclosure throughout your document, each of these terms appears to be a reference to the same product candidate. To the extent this is true, revise your disclosure to refer to this product candidate consistently throughout. Alternatively, please revise the beginning of this section to clearly explain the differences between ZYESAMI, RLF-100, VIP and aviptadil.

FirstName LastName
Richard Ackerman

Company Name
Big Rock Partners Acquisition Corp.

February 26, 2021 Page 4

~ Geert, Y@h00 RLFTF finance conversations

————————>

@Geert BRPA S-4 filings Product Designations

01/27/2021 ZYESAMI (RLF-100)
04/16/2021 ZYESAMI (Reformulation of RLF-100)
05/12/2021 ZYESAMI (Reformulation of RLF-100)
05/19/2021 ZYESAMI (Reformulation of RLF-100)
05/20/2021 ZYESAMI (Reformulation of RLF-100)
05/21/2021 ZYESAMI (Reformulation of RLF-100)

The first BRPA filing on 01/27/2021 confirms the letter. ZYESAMI = RLF-100. All of the subsequent filings refer to ZYESAMI being a reformulation of RLF-100. The inference is that ZYESAMI is based on Relief technology.

~ Raven, Y@h00 RLFTF finance conversations

IS THE CLINICAL RESEARCH PRESIDENT STILL EMPLOYED???

What’s really wrong now is that NRx’s cap is almost double that of RLF…duuh…quite surreal when you compare the pipelines and the profit sharing in the CA. I am sure RAM is anxious to pull the plug on OTCB. Probably the best time to buy RLF right now…

~ John, Y@h00 RLFTF finance conversations

If the Court decides that the CA is unenforceable, this will be the end of capitalism in the USA as we know it and we can all move to China then for better deals under their communist regime…

~ John, Y@h00 RLFTF finance conversations

Ms Pegs1, no earthly idea when or if!

Biotech giant helps itself without swallowing Galapagos whole
A ten-year collaboration gives biotech giant Gilead first rights to all of Galapagos’s pipeline.

Melanie Senior

The interesting part of Gilead’s expansive R&D collaboration with Galapagos is what it claims it is not: an acquisition. Instead, Gilead—helmed by Roche veteran Daniel O’Day—not only has paid Galapagos $3.95

https://www.nature.com/articles/d41587-019-00024-5?proof=t+target%3D

When comparing the different stages of Covid-19, should critical/severe cases require the same level of efficacy as the mild ones for EUA approval?

Read this from the NIH website:

"Regulatory decisions are made on benefit-risk balance and in a rapidly evolving pandemic two issues come in to play, namely the speed of drug approval and the urgency of clinical needs. The speed of developing treatments to the point of approval is key to protect patients from the infection as quickly as possible."

"Drug development of new biologicals or chemicals, other than vaccines, takes a minimum of 2–3 years even if there is a candidate that has shown efficacy in animal trials and have scaled down clinical trials to 6–12 months. Pre-clinical activities of manufacturing to establish product quality and the necessary safety studies normally take at least 2 years before clinical trials can start."

"Repurposed drugs, however, could appear on the market after simply completing one or more clinical trials. As the medical need for a drug increases and more patients die from the disease, THE BENEFIT OF THE DRUG INCREASES IN THE ASSESSMENT OF BENEFIT-RISK BALANCE."

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7677570/

This should be immediately approved and if there are any lingering questions make it a conditional approval.

~ Zorro, Y@h00 RLFTF finance conversations

A clinical trial has found that treatment with the immunomodulator interferon beta-1a plus the antiviral remdesivir was not superior to treatment with remdesivir alone in hospitalized adults with COVID-19 pneumonia. In addition, in a subgroup of patients who required high-flow oxygen, investigators found that interferon beta-1a was associated with more adverse events and worse outcomes. These findings were published today in the journal The Lancet Respiratory Medicine.
See H Scott post for link.

~ Equalizer, Y@h00 RLFTF finance conversations

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In case no one else posted this another possible covid cure has gone by the wayside.

https://www.nih.gov/news-events/news-releases/interferon-does-not-improve-outcomes-hospitalized-adults-covid-19

~ H. Scott, Y@h00 RLFTF finance conversations

I was trying to timeline Javitt's $NRXP claim that Relief "stopped funding when it thought aviptadil had failed".

Wasn't there a botched PR authored by NRXP on February 9 before US market open that alluded to the trial failing to reach primary endpoint? I cannot seem to find the original PR piece from that day that sent both stocks plummeting.

As I recall, that PR was later corrected, but brand damage was done at that point and it did not recover yet. We were all quite critical of NRx and Javitt at that time.

Many of us at the time were trying to understand how you could mess up a PR piece that badly. Perhaps it had some intent?

~ JP, Y@h00 RLFTF finance conversations

Replies ————————————-

>>> @JP I was just reading about that myself, go to page 28 of the Complaint.

~ Misho, Y@h00 RLFTF finance conversations

>>> @Misho Ah, yes, it starts on p31 actually, and I guess I just failed to connect that part of the complaint to this specific PR debacle, but clearly this is indeed what they are referring to. Thanks.

~ JP, Y@h00 RLFTF finance conversations

>>> Is it possible a Covid 19 Infection affected Dr. Javit's mind, as well as the entire NRXP Board of Directors, making them all think up is down, and North is South, and gawd forbid...East is West?

~ GeraldS, Y@h00 RLFTF finance conversations

DO SHAREHOLDERS STAND TO LOSE SUBSTANTIALLY IF NRXP CLAIMS TO ZYESAMI ARE ALLOWED TO STAND UNCHALLENGED??? DO BIG PHARMA, MMs AND GOVERNMENT FEUDAL LORDS STAND TO GAIN???

Someone made a really good point. We are close to an EUA. Despite the value drop the true value is near 1.00. Sad to see anyone abandon (for lack of a better word) this and succumb and sell low. Completely contrary to sound principles. I guess too many flippers. Totally agree now is the time to buy. I guess people forget or aren?t aware this jumped 38,000% last year upon announcements relating to FDA approval of IND and Houston Methodist study. A huge mistake to jump off the train which unfortunately has gone wrong direction with negativity, impatience, short tactics etc. Javitt is angry and trying to protect his #$%$ by misleading RLF investors into thinking RLF abandoned a contract and he knows at the same time his lawyers publicly offered to go to mediation. This means his lawyers believe they stand to lose something if they proceed to trial while also believing Relief also stands to lose something potentially if it goes to trial. Javitt?s comments have contributed to the fear and decline in SP. Relief is aware of this tactic and impact on its holders and must decide which path to take. It be nice to hear from management on the status of things as the lack of communication is also contributing to the decline in SP. We continue to lose the longer this drags on.

~ Mathieu, Y@h00 RLFTF finance conversations

NRXP must drop claims to Zyesami, Relief’s therapeutic per the Doctrine of Equivalents

https://grr.com/publications/the-doctrine-of-equivalents-in-patents/

The bad news is that NRx is now facing a lawsuit from its partner, Relief Therapeutics (OTC:RLFT.F), alleging that NRx failed to honor its obligations under the duo's collaboration agreement.

From Dr Joey on Facebook

I just finished recording the video! However, I must edit it in the morning before I feel comfortable releasing it. Im waking up at 6am and hope to have it done and released by 8am. My apologies for the delay. This time it's on me! ??But as always, I promise I try to get the best, credible information that I can find from trustworthy sources! I had a great phone call on Friday that gave some unique insight and I spent most of tonight updating the appropriate areas. Thank you for the support and I'm sorry for anyone disappointed. However, I think the video will ease some anxiety for sure! Goodnight everyone :)

~ Bigdog, Y@h00 RLFTF finance conversations

Don’t know why I never noticed this before but isn’t it coincidental that Javitt says in January, 2021 Relief abandoned the CA when that same month Relief bought Advita and included the right to market inhaled Aviptadil. Perhaps this is what caused JJ to throw a fit and go off the deep end.

~Mathieu, Y@h00 RLFTF finance conversations

Replies:

“violate the terms”

Yes the terms were violated before the actual signing.

They did not disclose their licensing agreement with SUNY Stony Brook.

This was required and it was not disclosed.

~ Saroja, Y@h00 RLFTF finance conversations

The other interesting comment from NRX SEC filing June 2021 was he listed that there is possibility that their drug zyesami might be ruled as an infringement on the valid patent rights of another party. Why would you document that on the SEC filing if your are claiming there is no patent?

~ CA_Newby, Y@h00 RLFTF finance conversations

Reply:

I think JJ was hoping he could strong arm RLF again into better terms. They caved to the initial pressure and added his revenue split. He probably thought that he could get more now so close to the EUA. These comments were in June soon after EUA filed. He already had a game plan, began paying his family right after the CA and he received $10.6 million for study plus $1 million for formulation study no questions asked. Since the game to send bloated receipts beyond 30% overage failed he is desperately trying to salvage, coverup or distracted from the real issue.

~CA_Newby, Y@h00 RLFTF finance conversations

NeuroRx announced yesterday preliminary findings from the phase 2b/3 trial of the intravenous delivery form of RLF-100™. According to NeuroRx, the preliminary data suggest that the administration of intravenous RLF-100™ could reduce the length of hospital stay among patients with respiratory failure due to critical COVID-19 compared to placebo plus maximal standard of care. No unexpected side effects were identified. The most common side effects of RLF-100™ in the clinical trial were mild to moderate diarrhea and systemic hypotension (low blood pressure). All potentially serious adverse effects were investigated by a board-certified critical care physician together with site investigators; none were deemed drug related.

https://relieftherapeutics.com/newsblog/relief-confirms-release-of-preliminary-findings-from-phase-2b-3-trial-of-intravenous-rlf-100-aviptadil

Zyesami is Relief’s therapeutic per the Doctrine of Equivalents

https://grr.com/publications/the-doctrine-of-equivalents-in-patents/

The bad news is that NRx is now facing a lawsuit from its partner, Relief Therapeutics (OTC:RLFT.F), alleging that NRx failed to honor its obligations under the duo's collaboration agreement. NRx counters that Relief stopped funding the drug's development back in January because the company believed it would fail.

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The conclusion, NRx Pharmaceuticals' value proposition centers on its severe COVID treatment called Zyesami (aviptadil). The company and its shareholders are hoping that the FDA will greenlight the drug soon in light of its impressive performance in the clinic. According to a recent peer-reviewed publication in the Journal of Infectious Diseases and Treatment, patients in an open-label trial at a single hospital and without randomization exhibited a ninefold survival advantage over those who received standard-of-care treatment. These initial results are highly unlikely to be enough to warrant an emergency-use authorization. But the company does appear to have a drug worth exploring further for severe COVID cases.
What's the upside potential? COVID-19 is expected to morph into an endemic respiratory illness. That means there will be a consistent need for novel coronavirus drugs -- especially for hospitalized patients with severe forms of the disease -- for a long time to come. Now, NRx still has a lot of work to do to get the drug on the market. But it does appear to be headed in the right direction. As such, this tiny drugmaker may sport a COVID-19 treatment capable of generating several hundred million dollars in sales per year for perhaps the better part of the next decade.

The bad news is that NRx is now facing a lawsuit from its partner, Relief Therapeutics (OTC:RLFT.F), alleging that NRx failed to honor its obligations under the duo's collaboration agreement. NRx counters that Relief stopped funding the drug's development back in January because the company believed it would fail.

This lawsuit could affect NRx's revenue haul for Zyesami. But the bigger picture is that the drug is showing promise in clinical trials. What's more, a sizable commercial opportunity exists for a medication capable of effectively treating covid patients suffering from respiratory failure. In short, this small-cap biotech might be gearing up for a monstrous run higher in the weeks and days ahead.

~ Zye of Relief, Y@h00 RLFTF finance conversations

It’s infuriating!!

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When I got in touch with my contact of Relief about the patent this is what he sent me this was September 2nd or 3rd.... . thought I'd repost it

Relief holds a patent covering potential formulations of RLF-100™ in the United States valid until at least July 2029, with extension opportunities up to five years as well as in the EU and Rest of World (Great Britain, Germany, Turkey, Spain, Switzerland, Netherlands, Denmark, Ireland, Austria, PRC and Mexico) valid until at least 2026, excluding extension opportunities comparable to the U.S. In part to further build the IP portfolio, Relief and AdVita Lifescience GmbH signed a binding term sheet in January 2021 for Relief to acquire all shares of AdVita. Relief will gain access to all AdVita assets including future pending IP rights that may cover RLF-100™ inhaled formulation specifications for the potential application of inhaled aviptadil in the treatment of lung diseases such as ARDS and pulmonary sarcoidosis.

~ Pat dude Pitbull Pat, Y@h00 RLFTF finance conversations

NRX paid pill tracker $360,000 in consulting fees supposedly to research inhaler technology. Zachary Javitt (JJ 31 yr old son signed contracts). The company is a startup by the son focusing on tracking compliance of medications. He isCEO of pilltracker. ZERO EXPERIENCE AS CONSULTANT TO INHALERS.

The son also received hourly salary from NRX for IT consulting totalling about $88,000 since CA signed.

What legitimate CEO would hire a consultant (your son) with zero experience in the field for a potential goldmine drug you are researching? What does pill tracker have to do with the study and EUA?

~ CA_Newby, Y@h00 RLFTF finance conversations

Replies:

Basically since the CA was signed, JJ funneled about $460,000 to his son Zachary. No wonder NRX doesn't want to open the books to audit. They won't be a report or anything useful from the $360,000 given to pill tracker for research on inhalers for aviptadil. They won't be able show show any meaningful work product and the whole transaction reeks of bad intentions.

The hourly consulting work his son received totalling $88,000. Seriously what was necessary that your own internal IT company couldn't perform. He doesn't have any specialty training for IT work.

~ CA_Newby, Y@h00 RLFTF finance conversations

Source is SEC documents NRX filed in June 2021.

~ CA_Newby, Y@h00 RLFTF finance conversations