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IF WE CONTINUE TO FUND VACCINE MAKERS iNTO THE TRILLIONS $$$$ THEY MAY EVOLVE INTO…THERAPEUTICS???
While working on the MERS vaccine, a different coronavirus prior to the current SARS-COV2 pandemic, a team of scientists discovered if they added two amino acids (protein building blocks) it can stabilize its spike protein into the pre-fusion conformation. This way more of the antibodies can be neutralizing.
The Moderna, Pfizer/BioNTech, Janssen (Johnson and Johnson) and Novavax vaccines contain the modified spike protein sequence that stabilizes the spike protein into the pre-fusion conformation. Scientists think that keeping the spike protein in the pre-fusion conformation may lead to more neutralizing antibodies. Time will tell whether the vaccines with the locked prefusion conformation spike protein will be more effective against SARS-CoV2 compared to the other vaccines which contain the wild-type spike protein.
https://dearpandemic.org/spike-protein-differences-between-different-vaccines/
Advance video to approximately 19:00…
I was wondering what the checklist for an EUA looks like so I found the below. JJ said in his filing he sent the FDA the GMP data last week.
2017 Guidance § III.D.2.a recommends that the following information be included in any request for an EUA:
Description of product and its intended use
Description of the product’s FDA approval status
The need for the product, including whether there are adequate, approved, and available alternatives
Safety and efficacy information:
Required safety information will vary by product and emergency.
It can include, for example, controlled clinical trials, bench testing, and/or clinical experience if the circumstances warrant.
Early discussions with FDA about the required safety and efficacy information are critical.
A discussion of risks and benefits:
A discussion of risks and benefits should include: (a) measures taken to mitigate risk or optimize benefit;
(b) limitations, uncertainty, and data gaps;
(c) contraindications; and
(d) actual and potential threats posed by CBRN agents that may be relevant.
Information on chemistry, manufacturing and controls, and the sites of manufacture, including the current good manufacturing practices (CGMP) status of those sites
Information on the quantity of product on-hand and surge manufacturing capabilities
Information comparable to an FDA-approved package insert or instructions for use;
drafts of fact sheets for healthcare professionals and recipients of the product;
and a discussion of the feasibility of providing this information in an emergency (a sample of instructions for use for an EUA diagnostic panel for the coronavirus is available on FDA’s website)
Information to support an extension of a label’s expiration date, if sought
Any right of reference (a right of reference means “the authority to rely upon, and otherwise use, data submitted from reports of an investigation or data previously submitted to FDA in support of an application, including the ability to make available the underlying raw data for FDA audit”)
~Zorro, Y@h00 RLFTF finance conversations
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities
I must confess I openly trusted the “evil one”!!! I’m back at “trust GOD and everyone else must pay cash”!!! That’s why RLFTF has a collaboration agreement.
Another violation is ALL media releases must be approved by both parties prior to release. Clearly NRX press releases over past several months did not go through RLF because they would've included RLF as a partner and standardized the naming convention.
~ CA_Newby, Y@h00 RLFTF finance conversations
——————————————————
PR with ACER are so great, published together :
"NEWTON, MA and GENEVA, SWITZERLAND – October 7, 2021 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”) and its collaboration partner, Relief Therapeutics Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), today announced that[...]"
This should have be this kind of PR with NRx, but they decided to make PR without consulting us.
Breach, breach, breach.
~Franz, Y@h00 RLFTF finance conversations
——————————————————
A breach of contract is determined by a judge not one party in the contract that decides there is a breach so you aren't still obligated to perform. According to the RLF legal brief and NRX, RLF paid ~10.6 million for studies. Per CA this is the negotiated amount PLUS the automatic 30% overage. Per CA, NRX is obligated to provide receipts and open books to audit if expenses exceed budget + 30%. Those overages are not declined but pending review and board approval. It is detailed in the CA that no overage can be paid until the overage charges are validated by RLF and approved by the board. Refusing audit and saying " it's legit, just pay" isn't a legal argument.
That is the rub. RLF hasn't been afforded a chance to pay additional expenses because NRX failed to comply with terms BOTH sides agreed to! NRX intentionally ignored CA terms because of their perceived belief it was breached, but a judge must hear both sides and make a ruling. It is only AFTER a ruling that a breach occurred is NRX free to proceed on their solo path. Until a judge adjudicates the case, both parties are still obligated to perform according to the CA provisions.
A modification to a written contract can't be unilaterally modified or voided orally by one party. It needs to be modified or nullified in the same manner it was executed.
IF NRX felt that a breach occurred in Jan they could have presented a written amendment to RLF for their agreement and signature or filed a breach of contract suit in a court of law. On the stage NRX needs to CYA and get any CA modifications in writing v claiming 10months later they are free from the CA because of perceived non payment. Too much is at stake to go rogue when there is a legal contract in place.
~CA_Newby, Y@h00 RLFTF finance conversations
Reply ——————————
Exactly right! I made a similar point earlier in the week. The only Party to the CA that seemingly has unilateral decision making rights spelled out in the actual agreement is Relief. There are certain rights that were also seemingly granted to Neuro regarding Inhaled Aviptadil; but then Relief’s rights to the inhaler version were equivalent with Neuro’s in that respect. That is, they both had the right per the CA to develop the inhaler on their own, or together, should they choose to do so.
Since both parties did not agree to the CA’s early termination, the CA is likely to be enforceable. It’s LIKELY to be…
However…ah yes, there are always caveats that cannot be ignored with respect to Law! However, my reading of the contract leads me to believe at least the First Requirement for a contract to exist between Neuro and Relief was satisfied, and it’s called “Consensus Ad Idem” (i.e., a “meeting of the minds”). Both company’s got together, discussed the terms of the CA, and then both company’s agreed to what they read by signing the Agreement. Simple right?!
Well…Maybe. At potential issue here, from a legal standpoint, is whether they BOTH had the SAME understanding about the meaning of each Clause contained in the agreement. This is where the Court will have to make an assessment regarding the aforementioned.
In Contract Law, EVERYTHING boils down to semantics and comprehension…did they BOTH have the EXACT SAME understanding with regard to each and every Clause contained therein? Or, put a different way, is it reasonable to say that a rational and reasonable person could/would have the same understanding of this Clause, or that Clause, based on a reading of the verbiage and terminology contained therein? Again…that will be what a Judge and/or Jury will be tasked with assessing.
There are other issues that could be raised regarding future, open ended (i.e., not well defined) Clauses within the CA as well, especially with regard to the aforementioned inhaler development. Typically, “open ended” Clauses that are not well defined are likely unenforceable, nor are said Clauses considered Contractually agreed upon, by the parties involved.
The CA may seem pretty straightforward upon anyone’s perusal of content. But in actuality, they rarely are when it rises to the point of litigation. I mean, honest to Pete, think about the highly public Impeachment Trial and Grand Jury Testimony of President William Jefferson Clinton. Does anyone remember how President Clinton was arguing semantically over the use of the word “Is” as a form of the Verb “to Be,” as the word relates to whether an event in question is historical or contemporary in nature?
“It depends on what the meaning of the word “Is” is” (President Clinton, Grand Jury Testimony, 1998). By the way…President Clinton’s “Semantics Argument” worked too!
My point is this…”Contracts” are NEVER (or are RARELY ever) simple. A layperson’s reading of a Contract entered into by other Parties, the proceedings of which they were not privy too during “Consensus Ad Idem” (i.e., “meeting of the minds”), MAY have one understanding about the Agreement…BUT, that “understanding” of the Agreement MAY NOT be the same “understanding” of the actual Parties to the Contract.
Again…that’s why these issues often require an assessment by a Jurist/Jury. The Solution is usually NEVER as “clear cut” as things may appear to be. If a Settlement is not attained, break out the Popcorn! ??
—Cheers—
~Brian A, Y@h00 RLFTF finance conversations
Who is the GOOD doctor??? Link???
Alexia Khammanivong was one of the first 100 COVID patients treated with Aviptadil, a medication credited with bringing her out of a monthlong coma.
The 21-year-old St. Petersburg resident was seven months pregnant when she developed complications due to COVID and went into a coma.
.
.
.
Germany recently greenlit a phase-2 trial of an inhaled version of the drug.
https://stpetestandard.com/stories/609235514-pregnant-mom-loses-son-but-sees-miraculous-recovery-after-application-of-aviptadil
Relief to launch Phase 2 trial of inhaled aviptadil in Germany for sarcoidosis
https://seekingalpha.com/news/3736522-relief-to-launch-phase-2-trial-of-inhaled-aviptadil-in-germany-for-sarcoidosis
A Great signal that Relief is fighting and confident of victory. While the PR was good news but it was a deeper signal that Relief’s legal team is on the charge ahead and sending a message to Dr J. So Stay strong….. we will be fine!!!
Relief Reports U.S. Collaboration Partner Announces Journal of Infectious Diseases and Treatment Publishes Positive Aviptadil Data in High Comorbidity Critical COVID-19 Patients w/ Respiratory Failure
10/15/21, 12:20 AM
GENEVA, SWITZERLAND / ACCESSWIRE / October 15, 2021 / RELIEF THERAPEUTICS Holding SA (SIX:RLF, OTCQB:RLFTF) (" Relief "), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (" NRx "), has issued a press release announcing that the peer-reviewed Journal of Infectious Diseases and Treatment has published positive trial data from a prospective, open label, administratively controlled trial of aviptadil in high comorbidity patients suffering from critical COVID-19 with respiratory failure. According to the press release, the study reported 60-day survival in 81% of those treated with aviptadil, compared to 21% survival among those who received standard of care treatment at the Houston Methodist Hospital (P<.0001). The press release also reports that a similar 9-fold advantage was seen in the cumulative probability of recovery from respiratory failure (P<.0001).
~ Mopar, Y@h00 RLFTF finance conversations
WHERE IN THE CA IS THE DECLARATION OF OWNERSHIP??? NO DECLARATION OF OWNERSHIP???
Collaboration agreements contain terms and conditions governing the relationship of the collaborators, eg by determining the: ... The focus of the collaboration may be, for example, for the parties to contribute expertise and know-how with respect to the design and development of certain software [therapeutic?].
https://www.rocketlawyer.com/gb/en/quick-guides/collaboration-agreements
So I want my prenuptial agreement renegotiated because I am special and I want more $ . I didn't know how much I could get when I signed.
I believe my spouse thinks the marriage failed in January and then abandoned me because they didn'tpay my credit card bill. If that is the case , I must be divorced now so I can now marry someone else but continue to use my ex spouses property and spend $.
I am doing this on my own and will send my ex the expenses I incurred over the past 9 months for my plastic surgery and dating app fees to seduce a new suitor! Of course don't forget I believe I was abandoned so my marriage is no longer valid in the eyes of the court so I am free to do anything.
~ CA_Newby, Y@h00 RLFTF finance conversations
IS ZYESAMI (TM) RLF-100/AVIPTADIL, TWEAKED??? BETTER THAN VACCINES??? BETTER THAN OTHER THERAPEUTICS???
VIP is known to target the VPAC1 receptor of the alveolar type II (ATII) cell and protect that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents. In addition, VIP prevents apoptosis, blocks cytokines, lowers TNFa levels, reverses CD4/CD8 ratio, and reduces cough and dyspnea in nonclinical and clinical studies.
Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and primarily concentrated in the lungs. In addition, VIP has been shown in more than hundreds of peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation says the company.
Because of its lack of toxicity and low cost of manufacture compared to proprietary biologics, VIP may be uniquely attractive to those focused on global countermeasures against COVID-19, says the company.
https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic
Pfizer scientists talk antibodies and vaccination.
Amongst the AdVita assets being acquired in this transaction, Relief will gain further pending intellectual property rights that may cover RLF-100TM inhaled formulation specifications and the potential application of inhaled Aviptadil in the treatment of Acute Respiratory Distress Syndrome (ARDS) and Checkpoint Inhibitor- induced Pneumonitis (CIP).
https://advita-lifescience.com/wp-content/uploads/20210120_PR_Relief_AdVita_EN.pdf
Maybe Relief should have never brought Javitt on in the first place as it seems like the Advita team is actually capable of publishing in a prestigious journal
https://www.nejm.org/doi/full/10.1056/NEJMc2000343
~Saroja, Y@h00 RLFTF finance conversations
I just saw Javitt at Arby's, he was being forklifted off his chair and rolled into the bathroom after choking down a couple beef and cheddars. I guess he needed a change of underwear....
~ Nicholas, Y@h00 RLFTF finance conversations
APR will be at CPHI worldwide in Milan from 9-11 November. I like how active they are.
https://www.linkedin.com/posts/apr-applied-pharma-research-s-a-_cphiworldwide-cphi2021-activity-6854407176354623488-gBDt
~ Bert-Jan, Y@h00 RLFTF finance conversations
DID BP PROMISED AN ISLAND??? WHAT DO YOU NEED TO REACH THE ISLAND, A BOAT???
What I wanted to post yesterday....
From the 8K:
''Relief’s demand that NRx cease development of a new Coronavirus vaccine in partnership with the government of Israel is especially shocking. The logic they seemed
to articulate in their complaint is that a successful vaccine against COVID-19 might reduce the number of patients with respiratory failure and therefore reduce the need for Zyesami''
This statement says it all for me. Trying to portray Relief as the bad guys. Of course Relief doesn't want more people to get ARDS so they can sell more AVIPTADIL. When you have a collaboration partner you discuss these kind of things or at least inform them of your plans.
This is from the collaboration agreement that YOU signed, Dr. Javitt:
5.1.
Unless otherwise provided herein, each of NeuroRx and Relief shall refrain from, and shall use commercially reasonable efforts to cause its Affiliates to refrain from, directly or indirectly (which for the avoidance of doubt shall include via any Person that is an equity holder of any of the foregoing) engaging in any development activities for, or conducting any unilateral bids to identify or solicit bids from contract manufacturers to synthesize or formulate, any drug or any related substance, product or treatment intended to be used to treat, combat, ameliorate, prevent or mitigate the effects of COVID-19 or any ailment reasonably related thereto that does or could reasonably be expected to compete against or reduce sales (or other monetization) of the Product. To the extent NeuroRx or any of its Affiliates controls any Third Party that are related to the Product or the development of the Product, this restriction shall also apply to each such Third Party.
~ Bert-Jan, Y@h00 RLFTF finance conversations
Ditto!! I’m personally fed up with the idea of white collar/street Marxist scum that adhere to their fundamental principle: “what’s mine is mine and what’s yours is mine as well”. Like hell it is!!!
1- Before EUA, NRXP must drop their claims on Zyesami (from the doctrine of equivalents also known as RLF-100/AVIPTADIL) and the new split is 60/40, RLFTF/NRXP
2- After EUA, all bets are off, we sue to stop them dead on their tracks!!! We move forward with ACER.
Dr, staying at the HIE doesn’t cut it, does it???
To me it seems like NRX is solely relying on their allegation that Relief abandoned funding. The only two points in the CA, that point to this are:
"Relief agrees that it shall fund the costs associated with the clinical development of the inhaled Product in the United States in reliance upon NeuroRx’s agreement to conduct, manage, supervise and oversee said clinical development. Should Relief not fund the clinical development costs, NeuroRx shall have the freedom to bring a replacement investor."
Which only relates to the inhaled product.
"“Product” means aviptadil (also known as RLF-100 or a drug name mutually agreed upon by the Parties and approved by the FDA) for any route of administration, including intravenous and inhaled use, as long as Relief funds the research and development costs for developing such use. Relief may use a different brand name in the Relief Territory (as defined below)."
The following point in the CA leads to the question, if the exceeding of 30% was already reached when Relief stopped the payments.
"That being said, any amended budget shall be subject to prior approval by Relief and NeuroRx and shall provide for reasonable cost overruns based on changes in the regulatory environment and requirements. Budget overages of less than 30% shall be automatically approved. In the event that Relief does not approve additional overages, NeuroRx shall be free to bring in other Persons in order to complete the Project."
In the complaint of the lawsuit in points 91 and following Relief states that it requested detailed information about the additional cost. Reasonable but contradictory to "Budget overages of less than 30% shall be automatically approved." But only, and only if they were within the 30%.
In point 97 of the complaint they mention the actual amount, NRX demanded:
"and then [Javitt]
threatened to bring in outside investors unless Relief's board pre-approved an even larger sum –
an incredible $18.75 million in expenditures (still without any detailed budget) within 24 hours."
This to me seems to be far more than 30% and in absence of detailed budget proposal the actual breach of the CA in this regard.
I am not a lawyer but with common sense you can only see a misconduct on one side. And I strongly believe that Relief has documented proof of the above mentioned request.
Dear Mr. Javitt,
if you read this please look inside yourself and ask the question if you prefer additional money - of which you have more than enough - or if you want to "bring hope to life". Because at the moment countless people lose their hope in humanity, holding the hands of their dying loved ones or standing at their graves. Every single day you delay this project.
Thank you!
~ Mr Dip Fisher, Y@h00 RLFTF finance conversations
From Dr Joey on Facebook.
I know I've been more silent than usual lately, especially considering the recent material events. I WILL release a video this weekend. I've gotten the information I was waiting for, so my apologies for the delay. And, don't fret too much with the posturing going on. This is an alpha male gorilla chest-beating battle at the moment. If you get too emotionally evolved, you will get lost in the Fray (which is also a great throwback music group by the way ...not as good as Coldplay of course, but who is?)
Anyway, if you watch my video I recorded sometime in July, you will notice I said I absolutely hate making predictions regarding EUA. Part of that reason is because I was afraid this was going to come down to a manufacturing/ processing issue. Unfortunately, it has. This is my opinion, but the timeline matches perfectly. I'll go over it in my video. Basically, I said nothing would happen regarding EUA until after first week in August.
After first week in August, (08/09/21) is when we started seeing some action..... specifically regarding the FDA asking for more info and the USPTO statement of use being published as "under examination" along with published pictures of ZYESAMI (tm) AVIPTADIL. Here's the rub...I was curious if Dr. J was going to go forward with his thinking because he also attached RLF-100(002) as part of the labeling, which necessarily gives a tip of the hat to RLF100 being the prior art !!!?? This helps immensely on the scale of "obviousness" , plus in combination with the CA. Some of those are legal terms that u will get into this weekend, but I'm putting it out there now in case you want to research.
A couple of other things I've noticed along the way is that some of confusing CDER and CBER rules. In my opinion, Aviptadil falls under the small molecules, and therefore "CDER" , regulations. These are specialized subdivisions of the FDA. Aviptadil acetate is what ZYESAMI was touted as in former filings by NRXP. In other words, acetate denotes a necessary buffer! If those on YB remember, I discussed about acetic acid and its use regarding the inhaled form being a hinging issue as well. But, I'll tie everything together this weekend. Sorry for the delay and GLTA!
~ Bigdog, Y@h00 RLFTF finance conversations
———————————————————>
Reply:
Regarding the term RLF-100, even the Sec questioned Nrx in one of their filings to clarify it:
Business of NeuroRx, page 173 https://www.sec.gov/Archives/edgar/data/1719406/000119312521118944/filename1.htm
Sec:
"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."
Nrx:
"Aviptadil is the generic name for synthetically-manufactured VIP, as distinct from the natural peptide. RLF-100 and ZYESAMI are both VIP-derived products, with ZYESAMI being a reformulation of RLF-100. We have revised the disclosures on page 179 of the Registration Statement as requested, and we have revised the disclosures throughout the Registration Statement to distinguish ZYESAMI, RLF-100, VIP and aviptadil."
Note that in one of Nrx's filings they discuss the Collaboration Agreement and it states:
"Each party will continue to own the intellectual property it possessed prior to the collaboration, and any intellectual property that is developed jointly by the parties relating to the RLF Product will be owned jointly by the parties and each party will have the right to use any joint intellectual property in its territory. Each Party is responsible for filing and prosecuting applications for patents, trademarks and other intellectual property in their respective territories and for the protection, maintenance, and enforcement of such intellectual property in such territory."
~ Zorro, Y@h00 RLFTF finance conversations
La lettre de Javitt aux actionnaires
https://ir.stockpr.com/neurorxpharma/sec-filings-email/content/0001104659-21-125683/tm2129746d1_ex99-1.htm
NRXP must drop the claim Zyesami is theirs or…who is Big Government/Big Pharma’s hitman(en)???
Probably get booted for too many songs. but can still read the board. Get your shades ready.
FRIENDS???
RELIEF REPORTS THAT ITS U.S. COLLABORATION PARTNER HAS ANNOUNCED PROGRESS ON WORLDWIDE COMMERCIAL SCALE DEVELOPMENT OF ZYESAMI™ (AVIPTADIL)
https://relieftherapeutics.com/newsblog/relief-reports-that-its-u-s-collaboration-partner-has-announced-progress-on-worldwide-commercial-scale-development-of-zyesami-aviptadil
The Doctrine of Equivalents may be on Relief’s side but time may not. NRXP wants “all things” lungs, assurances that the clinical trials on these 6 indications will be theirs 50-50:
In the coming year, we intend to initiate clinical trials for the following indications:
1- COVID “longhauler” syndrome: millions of Americans continue to suffer from reduced respiratory capacity and require home oxygen in order to maintain adequate blood oxygen levels.
2- Sarcoidosis: this chronic lung disease affects 185,000 Americans and causes pulmonary disability and death in 1% to 5% of those affected. The FDA has recognized Sarcoidosis as an orphan disease.
3- Acute Respiratory Distress Syndrome (ARDS): this is the condition that Prof. Sami Said first treated in the last years of his career, together with our Principal Investigator, Dr. J. Georges Youssef of Houston Methodist Hospital. Seven of the 8 patients they treated at Stonybrook University Hospital survived the Intensive Care Unit and 6 successfully left the hospital.
4- Checkpoint inhibitor pneumonitis: one of the most promising developments in cancer chemotherapy is the advent of checkpoint inhibitor drugs, of which Keytruda® (pembrolizumab) is the best-known example. While these drugs have shown promise in previously hopeless malignancies, they cause a highly unpleasant lung inflammation (pneumonitis) that is a challenge for patients and their families. There are reports in the medical literature of substantial relief being achieved with inhaled aviptadil.
5- Preservation of donor lungs both before and after transplant: There is a substantial pre-clinical literature on the effect of aviptadil in protecting donor lungs both while outside the body and after transplant. Dr. Youssef has treated some lung transplant patients under an investigator-sponsored IND with encouraging results.
6- Chronic Obstructive Pulmonary Disease (COPD): Highly provocative data have been shared with us regarding the potential for aviptadil to improve symptoms in patients with advanced COPD. More than 15 million Americans suffer from COPD and treatment at this time is largely confined to custom-compounded off-label use of inhaled steroids and bronchodilators. Our manufacturing partner, Nephron Pharmaceuticals, is one of the nation’s largest suppliers of custom inhaled medicines.
I could be wrong.
PERHAPS ZYESAMI IS AVIPTADIL, TWEAKED!!!
If you have a new formulation you would be required to do phase 1 dosing and safety studies. Give NRX credit for being bold but if you simply review their own press releases and the CA hard to understand how they took ownership of rlf and cannot see how they are willing to risk the profits they are actually entitled to. What is documented supports relief. The story told in nrx filing is a highly untenable narrative without any documentation. Relief financed this study, had safety studies conducted, had patented formulation which had already been used in humans with documentation. Nrx comes in and says we can tweak this and now we own 20 years of your data. I am not a lawyer but as a layman find this simply impossible to believe legally defensible. We will see. Both stocks will rise with any approvals and clearly Nrx has not responded to legal request for audits. Still believe that Javitts narcissism, actually believing he discovered and developed this drug will be the undoing of his messianic beliefs about himself, and likely will destroy both his and his brothers dream of creating a drug along with the wealth that would come their way. He sold relief on his relationships with fda and just continued upping the ante until relief and likely GEM said enough. Kind of like the guy who puts a fence on your property and then claims it’s my property now. I put up the fence. It works if you wait long enough but always fail if you get legal representation. If Neurorx has good lawyers they will put an end to this nonsense and not create more damages for shareholders of NRXP.
~ just the facts, Y@h00 RLFTF finance conversations
And now, "processed" :
https://iapps.courts.state.ny.us/nyscef/DocumentList?docketId=pgGwqeBmpZCRBLxrnghRIA==&display=all
We paid the fees.
~ Franz, Y@h00 RLFTF finance conversations
The doctrine of equivalents is a judicially-created doctrine that allows a court to find infringement when an accused instrumentality performs substantially the same function in substantially the same way to achieve the same result as the patented invention, or is insubstantially different from the patented invention.
https://www.finnegan.com/en/insights/events/recent-pharmaceutical-and-biotech-patent-case-law-on-infringement-under-the-doctrine-of-equivalents-051220.html
The doctrine of equivalents is a legal rule in patent law whereby a party can be liable for infringement even though the party does not literally or precisely infringe every limitation of a patent claim
Pharmaceutical companies therefore need sharp patent counsel both to protect their own inventions and to avoid infringement. Sophisticated companies rely on counsel to consider the doctrine of equivalents and its limitations at all phases of product development. Companies should be mindful during prosecution of patent applications to avoid inadvertently surrendering claim scope and barring themselves from later relying on the doctrine of equivalents. Conversely, companies looking to design around competitors’ patents must study the specification and prosecution history carefully to determine where they can safely practice without risking infringement. And, of course, companies require litigation counsel who can navigate this complex area of patent law.
https://www.iam-media.com/litigation/making-sense-of-the-doctrine-of-equivalents-in-pharmaceutical-patent-litigation
A patent infringement case between Cadence and Exela over the manufacturing process for injectable Tylenol ruled against Exela. The drug Tylenol is not under exclusive patent itself. The injection form however had many issues due to instability of the drug if specific manufacturing process, buffers and techniques weren't used. —— —> Exela tweaked to manufacturing process, modified the buffers and non active ingredients to create a stable, safe product. Cadence sued for infringement and won. <——— The courts did not feel that the tweaks resulted in a product that served a unique and different mechanism or treatment outcome. Even though the manufacturing differed from the original, they infringed and could not market their version.
~ CA_Newby, Y@h00 RLFTF finance conversations
Some of the fluctuations in intellectual property filings are related to legislative actions and judicial decisions that have occurred within the past decade.15
https://www.uscourts.gov/news/2020/02/13/just-facts-intellectual-property-cases-patent-copyright-and-trademark
RLFTF was shoplifted, yes??? No???
https://humanevents.com/2021/10/11/new-york-city-faces-major-shoplifting-surge/
"Jack Weinstein, Chief Financial Officer and Treasurer of Relief noted:
“Relief remains well funded and, based on current programs, we believe we have sufficient reserves to support multiple clinical programs through key value inflection points. Since the beginning of the year to June 30, we bolstered our balance sheet with CHF 30 million in equity financings. We have also been able to take advantage of the flexibility provided by our additional share listing, giving the company, as of September 24, an available cash position of CHF 40 million.”
https://relieftherapeutics.com/newsblog/relief-reports-half-year-2021-results-and-provides-corporate-update
Joe K, I do not know the answer to your question but I am of the opinion that RLF-100/Aviptadil is better than vaccines, antivirals and other therapeutics out there!
VIP is known to target the VPAC1 receptor of the alveolar type II (ATII) cell and protect that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents. In addition, VIP prevents apoptosis, blocks cytokines, lowers TNFa levels, reverses CD4/CD8 ratio, and reduces cough and dyspnea in nonclinical and clinical studies.
Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and primarily concentrated in the lungs. In addition, VIP has been shown in more than hundreds of peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation says the company.
https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic
ARE RELIEF’S AVIPTADIL BENEFITS MULTI DIMENSIONAL??? SHOULD WE DEFEND AVIPTADIL ANTI-INFLAMMATORY APPLICATION???
Try to Attack Your Own Patent
This tip is less intuitive than some of the others, but possibly your best bet at creating a valuable patent. You want to be prepared for questions by the USPTO when you submit your application. The better prepared you are to defend your design, including its novelty, utility, and non-obviousness, the more likely you are to receive a patent.
Likewise, you should assume that competitors will want to find ways to profit from a similar design. Think like a competitor and try to find ways they might circumvent your patent – with as many variations as possible.
https://michelsonip.com/how-to-strengthen-your-patent/
Our development of ZYESAMI is based on intellectual property licensed to us by the Research Foundation of the State University of New York. Ain’t that sweet??? Who else is with rfsuny???
SUNY Upstate Medical University is working with Pfizer to study a new mRNA-based flu vaccine, which is the same technology that was used in the Pfizer BioNTech COVID-19 vaccine
https://www.rfsuny.org/
WHO ELSE IS ENGAGED IN IP THEFT???
The Wall Street Journal published a commentary in 2020 written by a Corona manufacturer, Steve Saleen, who stated that the Chinese government stole the plant he opened with them as a partner and then claimed his U.S. patents and intellectual property.
http://mypub.iebjpub.com/article/Corona+Manufacturer+Claims+Chinese+Officials+Hijacked+His+Company/3747042/671119/article.html
WHO ELSE IS INTERESTED IN A PIECE OF RELIEF’S AVIPTADIL IP???
"under Section 5.1 of the Collaboration Agreement, neither party may engage in any development activities for any drug or related product or treatment intended to be used to treat, combat, ameliorate, prevent or mitigate the effects of COVID-19 that can or may reasonably be expected to compete against or reduce sales (or other monetization) of aviptadil."
JJ signed this collab agreement on September 18, 2020.
One breach among others...
Good luck to defend this.
~ Franz, Y@h00 RLFTF finance conversations
A Phase 2 clinical trial investigating the inhaled sarcoidosis therapy aviptadil — also known as RLF-100, and designed to block inflammation in the lungs — has been cleared to start in Germany.
The clearance by the German medical regulatory authority Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) was given to AdVita Lifescience, the original developer of aviptadil, which was recently acquired by Relief Therapeutics.
“Receiving regulatory clearance to begin a phase 2 clinical trial of inhaled aviptadil marks another clinical milestone for Relief and our subsidiary, AdVita,” Raghuram Selvaraju, chairman of the board of Relief, said in a press release.
https://sarcoidosisnews.com/2021/09/10/phase-2-trial-inhaled-sarcoidosis-therapy-aviptadil-cleared-germany/
Remember??? Does this become our new spearhead while attorneys hash it out in court???
The U.S. Food and Drug Administration has granted orphan drug designation to RLF-100 (aviptadil), Relief Therapeutics’ investigational inhaled therapy for sarcoidosis.
Such status is given to treatment candidates with the potential to be safe and effective in rare diseases — defined in the U.S. as those affecting fewer than 200,000 people — that have no approved treatments, or in cases in which the potential therapy shows significant benefit over existing treatments.
https://sarcoidosisnews.com/2021/08/13/inhaled-therapy-rlf-100-sarcoidosis-earns-fda-orphan-drug-status/
As part of a new agreement with AdVita Lifescience, Relief Therapeutics will acquire the intellectual rights for the specifications and potential applications of an inhaled formulation of RLF-100 (aviptadil).
Relief has been collaborating with NeuroRx to advance the development of RLF-100 to treat patients with severe COVID-19 respiratory complications and other lung disorders, including pulmonary sarcoidosis.
https://sarcoidosisnews.com/2021/01/28/deal-gives-relief-therapeutics-intellectual-rights-potential-sarcoidosis-therapy-rlf-100/
Price drop 12%-14%
I wanted to share some thoughts and strategies.
The price has dropped today between 12% to 14% - I managed to squeeze a top up at 0.0896.
The key to remember is this : posts often focus on shorts, but the most important people are the market makers. Market makers only make money on SELLs and BUYs. On the margin between the two. If everyone is holding, a market maker makes no money at all, zero. So, whatever the stock, market makers need volume to make money. How do they do it when everyone is holding - they generate volume, by either raising or dropping the price, depending on "sentiment".
Sentiment ? Market makers, and big players, have tools which automatically check the sentiment on a share by monitoring social media and the quality of SELLs and BUYs. You can pay a lot of money to subscribe to such tools. What I do often, using this board, is calculate what the "sentiment" is, using my own very simplistic Ilka calculations, and, going by the posts on the board since Friday, including one of my own, I calculated that, since Market Makers need any type of volume to make money and the sentiment is very negative because of you know what, that there would be about a 10% drop today. I wasn't too far, it was, at its maximum, a 14% drop. What that does for a Market Maker is generate volume because for some retail investors 0.10 will have been a psychological wall given the current legal situation, and they will sell. This in turn will have others, like me earlier, who will buy - market maker makes money ! Sometimes the market makers' calculations are even more complex : they will factor in automated robots, the ones used by the much bigger players. This is what happened today : by dropping the price significantly, automated robots kicked in and dumped millions of shares, taking the price further down, and many retail investors with them; those robots then re-purchase either to hold, or to dump again when they've made 3% to 5%, because 5% on $100K is $5K.
This is why, as most on here know, it is so important to know what you own and what you think the "long outlook probability" is like, otherwise you get caught in market makers games (nothing negative - they need those games to make money - if I was a market maker I would do the exact same thing) and you sell, or you miss out on a top-up because you are scared.
The point of my post : when the price moves significantly in the absence of any news always remember both the current "sentiment" and the market makers needs to have volume to make money. Then go back to your own due diligence and you will know what to do for yourself.
On this, let's see what this week brings.
~ IlkaS, Y@h00 RLFTF finance conversations
The Relief Agreement similarly affords Relief Therapeutics the right to fund the development of ZYESAMI™ for inhaled use. The Relief Agreement provides that in the event Relief Therapeutics chooses not to fund the inhaled use of ZYESAMI™, we would be free to bring in other investment capital for this purpose. Relief Therapeutics has chosen not to fund the inhaled use of ZYESAMI™ and we have proceeded to develop this drug with other sources of capital. Despite Relief Therapeutics’ knowledge that it has not funded these and other areas of the collaboration agreement and despite the non-reproducible nature of the formulation and stability data Relief Therapeutics provided as part of its partnership contribution, Relief Therapeutics continues to advise its shareholders that it is entitled to the previously contemplated share of profits from intravenous and inhaled ZYESAMI™.
We advised Relief Therapeutics of the stability discrepancies in November and December 2020. In January 2021, we notified Relief Therapeutics that the formulation documented in the IMPD yielded only 60-day stability and began developing a longer stability product, ZYESAMI, aiming for a shelf life of at least one year. The Relief Agreement provides that Relief Therapeutics is to pay all costs of formulation, stability and CMC should such costs arise. Relief Therapeutics has declined to pay any of the costs associated with NRx’s development of ZYESAMI™ and has issued advice to its shareholders alleging that Relief Therapeutics owns all intellectual property related to ZYESAMI™. On April 19, 2021, Relief Therapeutics issued a press release acknowledging that “Relief notes that while there are stability issues with the formulation that Relief brought to the collaboration, all of these problems were understood by all parties at the time of the execution of the Collaboration Agreement and that efforts to resolve those issues were contemplated by the [Relief Agreement].” As of July 31, 2021, Relief Therapeutics has not funded any costs of re-formulation of aviptadil into a shelf stable product. There is no provision in the Relief Agreement that gives Relief Therapeutics access to development assets that Relief Therapeutics has not funded, nor does Relief Therapeutics own any patents that block NRx’s development of ZYESAMI™.
Our development of ZYESAMI is based on intellectual property licensed to us by the Research Foundation of the State University of New York. We have a commercial partnership with Relief Therapeutics Holdings, SA and its wholly owned subsidiary Therametrics Discovery AG (collectively, “Relief Therapeutics”) in which we and Relief Therapeutics have agreed to share profits from ZYESAMI for certain indications, based on Relief Therapeutics’ funding of our development efforts.
ZYESAMI has demonstrated a statistically-significant reduction in mortality rate when compared to placebo in treating critical COVID-19 and respiratory failure in patients, which used a written statistical analysis methodology agreed in advance with the FDA that controls for differences in baseline severity of disease. If one does not control for baseline severity, a numerical but not statistically-significant advantage is observed. ZYESAMI has been approved for Emergency Use by the Nation of Georgia with pending applications in surrounding Caucasus nations and has been submitted for “Emergency Use Authorization” (“EUA”) to the FDA, where it is awaiting a regulatory decision. Applications to other regulatory authorities worldwide are currently in process. Additional Phase III trials of ZYESAMI are now being conducted by the U.S. National Institutes of Health (“NIH”) and by an entity funded by the U.S. Biomedical Advanced Research and Development Authority (“BARDA”).
https://seekingalpha.com/filing/5708277
MYOCARDITIS???
Inflammation of the middle layer of the heart wall.
Myocarditis is usually caused by a viral infection. A severe case can weaken the heart, which can lead to heart failure, abnormal heartbeat, and sudden death.
PERICARDITIS???
A swelling and irritation of the thin saclike membrane surrounding the heart (pericardium).
Pericarditis may be caused by a viral infection or heart attack. In many cases, the cause is unknown.
~ MAYO CLINIC
Myocardial fibrosis is defined by a significant increase in the collagen volume of myocardial tissue. It is a complex process that involves all components of the myocardial tissue and can be triggered by tissue injury from myocardial ischemia (hypoxia), inflammation, and hypertensive overload.
~ Mayo Clinic Proceedings
We conclude that VIP [Vasoactive Intestinal Peptide] infusion increased myocardial VIP concentration and was able to reverse existing myocardial fibrosis suggesting a possible therapeutic role for a VIP based therapy in cardiac failure.
https://pubmed.ncbi.nlm.nih.gov/31449808/