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@Gigantic Balls My prediction is not that the conference in his platform for approval. I believe they received approval already and will announce on Monday. Premarket is most likely. +4 days to announce per SEC from Friday makes Tuesday thr latest. ~ Jacob, Y@h00 RLFTF finance conversations
Although neonatal RDS is still the main indication of surfactant therapy, other pathological processes received considerable attention and major research has been dedicated to explore the role of surfactant in their management, Meconium aspiration syndrome (MAS) and congenital pneumonia are two worthy examples.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4949959/
According to Verified Market Research, The Global Pneumonia Therapeutics Market was valued at USD 2.2 Billion in 2020 and is projected to reach USD 7.2 Billion
https://www.verifiedmarketresearch.com/product/pneumonia-therapeutics-market/
Porcine versus bovine surfactant therapy for RDS in preterm neonates: pragmatic meta-analysis and review of physiopathological plausibility of the effects on extra-pulmonary outcomes
https://respiratory-research.biomedcentral.com/articles/10.1186/s12931-019-1267-8
HOW ABOUT AN INFUSION OF SAFE AND EFFECTIVE ZYESAMI(TM) FOR ALL SOON-TO-BE MOMS???
Which treatment is prescribed for the newborn with meconium aspiration syndrome?
Suctioning the baby's upper airways, including the nose, mouth and throat. Giving the baby supplemental oxygen by hood or mechanical ventilator. Tapping on the baby's chest to loosen secretions, a technique known as chest physiotherapy. Antibiotics to treat infection.
http://emedicine.medscape.com/article/974110-medication
GOVERNMENT INSTITUTIONS IN CONTROL OF PROCESS!!! ARE THEY HELPING???
Frustrating that Merck can enroll 1,000 people in 4 weeks and then in our Activ trial which is supposed to accelerate Covid solutions we are at 1/4 the number in 3-4 months time ...
This is possibly the power of having thousands of sales people and partnering w BP ?
Also interesting that Merck unblinded the results ?
Something seems unusual about the Merck trial and circumstances. Plus Merck results are only to 29 days. ~ Equalizer, Y@h00 RLFTF finance conversations ———
EIDD-2801 resembles the chemicals with which replicating viruses build their genes. “When the virus incorporates molecules from the drug into its RNA, there is a lethal accumulation of mistakes — an error catastrophe,” said Prof Ralph Baric, a coronavirus expert at the University of North Carolina who has been working for several years with colleagues at Emory to develop EIDD-2801.
It is in the same class of drug as Gilead Sciences’ remdesivir, the antiviral that has so far shown most promise for treating Covid-19 patients in trials, but they work in a different way, said Roger Perlmutter, Merck’s head of research.
“Remdesivir blocks an enzyme that the virus needs to replicate,” he said. “EIDD-2801 causes the enzyme to make mistakes and these errors lead to a catastrophic mutational burden.”
https://www.ft.com/content/de7df1ee-c566-4c79-9b3e-9b7d792d424c
CAN THE BEST OF VACCINES OR OTHER ANTIVIRAL DRUG, DO THIS???
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
ADVANCED WOUND CARE
WITH NEXODYN® AOS
Wound Cleansers: a Growing Category in a Growing Market
Advanced wound care is a fast growing market mainly composed of 4 main categories: dressings, wound cleansers, negative pressure wound therapy devices and biologics.
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. The main drivers of this growth are the aging population and the increased prevalence of chronic diseases, such as diabetes.
Non-Healing Wounds: a Challenge for Patients and Society
It is estimated that 1 % to 2 % of the population will experience a chronic wound during their lifetime in developed countries2 and this rate is increasing year after year. Stalled wounds may persist for months, even years3,4 before healing.
Due to this situation, non-healing wounds represent an economic burden for health services and patients. In 2015 only, chronic wounds represented a global expenditure of $143 bn.
https://www.apr.ch/apr-pharma-products/therapeutic-pharma/wound-management/
WHAT DO PATIENTS SAY WHEN NEXODYN(R) AOS IS SPRAYED ON THEIR WOUND??? RELIEF!!!? ——— Nexodyn® AOS is a sprayable solution for Wound Care with ancillary antimicrobial properties intended for use in the debridement, irrigation, cleansing and moistening of chronic wounds and acute wounds, post-surgical wounds, cuts, abrasions, burns and other lesions.
https://www.apr.ch/apr-pharma-products/medical-prescription/nexodyn-wound-healing/
STOP STALLING, RESTART HEALING
For those who haven't seen this, according to American College of Cardiology practice notes, Remdesivir might help a little but if people are on mechanical ventilation or ECMO, "this population is associated with a modest increase in mortality." (Practice point #3)
https://www.acc.org/latest-in-cardiology/ten-points-to-remember/2021/02/16/15/41/should-remdesivir-be-used-for-the-treatment
~ Kevin, Y@h00/RLFTF finance conversations
GENEVA, SWITZERLAND / ACCESSWIRE / September 30, 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, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA ("APR"), reported data published in the peer reviewed Journal of Wound Care, indicating that the company's Nexodyn(R) acid-oxidizing solution (AOS), developed with APR's proprietary Tehclo(R) technology, was found to be a highly effective treatment to support wound healing in infected or non-infected hard-to-heal leg ulcers. The data also confirmed the safety and tolerability of Nexodyn(R).
https://www.biospace.com/article/releases/relief-s-subsidiary-apr-applied-pharma-research-reports-data-published-in-journal-of-wound-care-indicating-nexodyn-r-aos-highly-effective-treatment-to-support-healing-of-hard-to-heal-leg-ulcers/
“Venous Leg Ulcer Treatment (VLU) Market Size, Share and Global Trend by Product (Compression Therapy, Advanced Wound Dressings, Others), By End User (Hospitals, Specialty Clinics, Homecare Settings, Others), and Regional Forecast, till 2026,” the market was worth USD 2.95 billion in 2018 and will exhibit a CAGR of 6.4% during the forecast period, 2019-2026.
https://www.globenewswire.com/news-release/2020/03/03/1994141/0/en/Venous-Leg-Ulcer-Treatment-Market-to-Rise-at-6-4-CAGR-till-2026-Increasing-Investments-in-Product-R-D-to-Aid-Growth-says-Fortune-Business-Insights.html
Zyesami (Aviptadil) is a formulation of synthetic human Vasoactive Intestinal Peptide (VIP), which was first discovered in 1970. NRx was the first to formulate aviptadil for human intravenous and inhaled use under the "Good Manufacturing Practices" standards in 2020.
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.
https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic
In July Attorney Renz Whistleblower, under penalty of perjury, stated that she estimated at least 45K people had died from the Covid-19 Vaccine. USA Today Fact Checkers and other fact checking services claimed that to be “misinformation.” Today’s revelations solidify that the “Trusted News Initiative” is actually the source of misinformation and propaganda, and that Attorney Thomas Renz Whistleblower was correct all along.
After proving that over 45K people have died from the COVID-19 vaccine, Attorney Renz then moved his attention to focus on the amount of people that are being killed in American hospitals by Dr. Anthony Fauci’s instituted protocol of Remdesivir.
Attorney Renz is also in possession of Remdesivir death data from the Medicare Tracking System that has been withheld by the government from our citizens.
The Remdesivir data reveals of the 7,960 beneficiaries prescribed Remdesivir for Covid-19 2,058 died. That is 25.9%.
46% of people died within 14 days of the Remdesivir Treatment. The Remdesivir Treatment was established in U.S. Hospitals at the direction of Dr. Anthony Fauci.
Serious adverse events were reported in 131 of the 532 patients who received Remdesivir. That is 24.6%.
Attorney Renz says ” This begs the question… Why is this the protocol in American Hospitals? Does this appear “Safe and Effective” to you?”
https://www.newswars.com/bombshell-from-attorney-thomas-renz-nearly-50k-medicare-patients-died-soon-after-getting-covid-shot/
MEDICAL COUNTERMEASURES, or MCMs, are FDA-regulated products (biologics, drugs, devices) that may be used in the event of a potential public health emergency stemming from a terrorist attack with a biological, chemical, or radiological/nuclear material, or a naturally occurring emerging disease.
https://www.fda.gov/emergency-preparedness-and-response/about-mcmi/what-are-medical-countermeasures
ARE GLOBAL COUNTERMEASURES THE BADDIES??? ———
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. ———
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.
https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic
IV. EMERGENCY USE OF ELIGIBLE FDA-APPROVED MCMs WITHOUT AN EUA ———
Section 564A allows FDA to facilitate certain emergency activities involving FDA-approved MCMs without an EUA. This authority is independent of the EUA authority under section 564. In the past, to address concerns about potential FD&C Act violations related to the activities discussed in this section involving MCMs, FDA has either: (1) exercised its enforcement discretion with respect to the activity; or (2) issued an EUA to ensure that use of such MCMs remains covered under any otherwise applicable protections under the PREP Act61 (discussed in section VII of this guidance). MCMs used under this authority qualify for applicable PREP Act protection.62 ———
In some cases, FDA and CDC may coordinate activities under section 564A authorities including the issuance of an emergency dispensing order, waiver of cGMPs, waiver of REMS, extension of expiration dating, and/or issuance of EUI for specific MCMs.63
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities
DOES RLFTF HAVE ENOUGH TIME TO REALIZE/MAXIMIZE THE PROMISES OF AVIPTADIL BEFORE THE PATENT EXPIRES???
2006-03-07…Application filed by MondoBiotech AG ———
2008-07-03…Publication of US20080161237A1 ———
2012-05-15…Publication of US8178489B2 ———
2012-05-15…Application granted
Status ———
Active - Reinstated ———
2029-07-03…Adjusted expiration
https://patents.google.com/patent/US8178489B2/en
THE PATENT LAWYER MUST BE BUSY ——— There are a number of nuances when it comes to being eligible for patent term extension and when it comes to applying, a patent lawyer can help with the process. Patent holders should be warned that there are a number of ways that a pharmaceutical patent could be rendered ineligible for patent term extension.
Work with an experienced attorney to ensure that patents are rendered eligible.
https://www.whitcomblawpc.com/blog/patent-term-extension
ALZHEIMER’S, COAGULATION GENES AND VIP
One clinical use of VIP follows early diagnosis of dementia. Neuronal loss is rarely sudden; the time from detection of gray matter nuclear atrophy to when overt dementia begins can be long. VIP dosing at 300-600mcg/day, taken over 6-9 months has been shown to be safe and effective. We have shown (unpublished) that the mechanism of VIP CORRECTION OF EARLY DEMENTIA usually stems from CORRECTION OF THE UNREGULATED OVER-EXPRESSION OF COAGULATION GENES using VIP provides clinical benefit seen in a small, but ever-growing number of patients. In younger-aged Alzheimer’s patients, improvement coincides with correction of coagulation genes, which in turn reduces overproduction of coagulation gene products.
https://www.survivingmold.com/save-vip/additional-uses-of-vip
If you have factor V Leiden, you inherited either one copy or, rarely, two copies of the defective gene. Inheriting one copy slightly increases your risk of developing blood clots. Inheriting two copies — one from each parent — significantly increases your risk of developing blood clots.
https://www.mayoclinic.org/diseases-conditions/factor-v-leiden/symptoms-causes/syc-20372423
The Alzheimer's disease diagnostics and therapeutics market was valued at USD 6,632.82 million in 2020, and it is expected to reach approximately USD 9,073 million in 2026, registering a CAGR of nearly 5.36% during the forecast period, 2021-2026.
https://www.mordorintelligence.com/industry-reports/alzheimers-diagnosis-and-drugs-market
Chronic kidney disease (CKD) is a long-term condition in which the kidneys do not work correctly. It has a high prevalence and represents a serious hazard to human health and estimated to affects hundreds of millions of people. Diabetes and hypertension are the two principal causes of CKD. The progression of CKD is characterized by the loss of renal cells and their replacement by extracellular matrix (ECM), independently of the associated disease. Thus, one of the consequences of CKD is glomerulosclerosis and tubulointerstitial fibrosis caused by an imbalance between excessive synthesis and reduced breakdown of the ECM.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5354133/
Dialysis requiring renal failure is a silent epidemic. Despite an annual mortality of 24% the dialysis population has increased by 1-4% per annum. Regardless of the initial injury, tubulointerstitial fibrosis is a feature of the renal pathology and it inversely correlates with declining renal function. Current agents display little efficacy against tubulointerstitial fibrosis. Clearly, therapies effective against tubulointerstitial fibrosis and able to preserve kidney function are needed. Vasoactive intestinal peptide (VIP) has been shown to reverse pre-existing cardiac fibrosis. We sought to determine whether VIP is effective in tubulointerstitial fibrosis.
https://pubmed.ncbi.nlm.nih.gov/32014488/
For patients not covered by health insurance, a single hemodialysis treatment typically costs up to $500 or more -- or, about $72,000 or more per year for the typical three treatments per week. Injectable medications and vitamins can add hundreds of dollars to the cost, depending on what is prescribed.
https://www.google.com/search?q=national+cost+dialysis&ie=UTF-8&oe=UTF-8&hl=en-us&client=safari
Between 5.3 and 10.5 million people require dialysis or transplantation, although many do not receive these treatments due to lack of resources or financial barriers.
https://www.theisn.org/blog/2020/11/27/more-than-850-million-worldwide-have-some-form-of-kidney-disease-help-raise-awareness/
Kidney interstitial fibrosis (IF) can be defined as the accumulation of collagen and related molecules in the interstitium. Interstitial collagen is normally present in the kidney, particularly type I and III, which serve as structural scaffolding.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3354760/
Results: Interstitial fibrosis performed well overall as a predictor of progression to dialysis. On average, patients with >50% fibrosis progressed more rapidly than those with either 25-49 or 0-24% fibrosis with a median time to dialysis of 1.2, 6.5 and >10 years, respectively.
https://www.karger.com/Article/Fulltext/449511
DIALYSIS??? MY GOD, WHAT IS THIS, THE DARK AGES???
FROM MYOCARDIAL FIBROSIS TO CONGESTIVE HEART FAILURE
Congestive cardiac failure has become one of the major health challenges of the 21st century and new therapies are needed to address this problem. The concentration of vasoactive intestinal peptide (VIP) in the heart has been shown to decrease as fibrosis (the pathology leading to heart failure) increases and to become undetectable in end stage cardiomyopathy. We sought to determine whether replenishment of myocardial VIP might treat myocardial fibrosis and therefore represent a new therapeutic target.
https://pubmed.ncbi.nlm.nih.gov/31449808/
Cardiovascular Drugs Market Size is Projected to Reach USD 63.96 Billion at CAGR to 3.8% by 2026.
https://finance.yahoo.com/news/cardiovascular-drugs-market-size-projected-053000512.html
IF THERE IS A RISK OF HARM THERE SHOULD BE CHOICE IN THE MATTER
https://rumble.com/vmgydn-wvuh-to-require-all-employees-to-be-vaccinated-or-will-face-voluntary-termi.html
RISK OF HARM???
https://rumble.com/vmx5rj-perth-australia-nurses-protest-vaccine-mandate.html
RISK OF HARM???
No, I don’t have any means to communicate with Dr Joey other than posting away, just as you do, in this forum. I did see a post on a board alluding to the fact that Roche is a Swiss pharma trading in the OTCQX. Roche is also an ADR. RLFTF could be next.
https://www.roche.com/investors/us_investors/us_investors_faq.htm
Post from Dr Joey Johnson on FB ———
People have been asking me if I'm going to sell after we get Emergency Use Authorization? Of course not! Or, if I think life is over if we don't get EUA? Again - of course not! ———
Here is something for you to think about if you have considered asking me or any other Longs this question:
1. Non-Covid 19 ARDS + pulmonary sarcoidosis = more $ via peak sales est. than COVID-19 Induced ARDS ———
2. APR TD-011 is where the bigger money pot is! We'll actually make more $ from this APR drug than inhaled Aviptadil for ARDS with full approval! ———
3. Besides Aviptadil and it's various forms, the following drugs will launch this year:
a) APR TD011
b) SENTINOX
c) NEXODYN
d) ACER-001 (2021/2022) ———
I'm in the Class of 2025! In other words, I've got my eyes set on holding at least half of my shares until then! GLTA!
——>
I’m here for Aviptadil, but after seeing Dr Joey post I researched RLF owned APR & the APR treatment for EB;
EB affects ~500,000 ———
& annual treatment varies from $10k to $300k per year per patient ———
& here is what I found:
For Epidermolysis Bullosa, no approved treatments or cure are available. ———
The standard of care is currently palliative treatments for blisters and wounds all over the body for the entire life. ———
Itching, pain, and scarring strongly reduce the quality of life while persistent skin inflammation is correlated to tumor incidence and death. ———
EB imposes a major burden for global health care ———
The cost of the treatment of a severely affected patient in the United States can approach $300,000 per year, wound care supplies for those with EB are estimated more than $10,000 per month. ~ Equalizer, RLFTF @ Y@h00 finance conversations
—————->
The U.S. Food and Drug Administration (FDA) has granted orphan drug status to APR-TD011, a spray therapy candidate for the treatment of epidermolysis bullosa (EB). ———
This designation is intended to encourage the development of therapies for rare and serious diseases, which are expected to outperform existing alternatives. ———
Among its benefits are seven years of market exclusivity, exemption from FDA application fees, the agency’s assistance in clinical trial design, and tax credits for trial expenses. ———
https://epidermolysisbullosanews.com/2019/12/18/spray-therapy-apr-td011-s-fda-orphan-drug-status-treat-eb-epidermolysis-bullosa/
MC67, a very sad state of affairs. I hope it won’t get any worse than it already is.
https://thehill.com/policy/national-security/572270-afghan-evacuation-flights-to-us-remain-paused-indefinitely-due-to
As the blood travels around the body, it carries the virus to different body organs, including the liver, the skin, the central nervous system, and the spleen. In the skin, the measles virus causes inflammation in the capillaries.
https://www.medicalnewstoday.com/articles/37135
Measles may cause several respiratory complications such as chronic obstructive lung disease, pneumonia, with subsequent development of chronic suppurative lung disease, giant cells pneumonia or progressive respiratory insufficiency.
https://pubmed.ncbi.nlm.nih.gov/19385330/
Young infants with measles requiring respiratory support have a significant risk for death and long-term complications. Even in developed countries, the occurrence of spontaneous air-leaks and acute respiratory distress syndrome (ARDS) still represent the most severe clinical presentation in early childhood, with a high fatality rate. A clinical series review from a tertiary university paediatric intensive care unit (PICU) was undertaken.
https://pubmed.ncbi.nlm.nih.gov/20012881/
Myocardial fibrosis is responsible for an increase in intrinsic myocardial stiffness that may alter the LV diastolic properties.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2889378/
We conclude that VIP 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/
The global cardiovascular drugs market is expected to grow from $87.79 billion in 2020 to $92.41 billion in 2021 at a compound annual growth rate (CAGR) of 5.3%. The growth is mainly due to the companies rearranging their operations and recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $107.77 billion in 2025 at a CAGR of 4%.
https://www.globenewswire.com/en/news-release/2021/05/17/2230401/28124/en/Insights-on-the-87-Billion-Cardiovascular-Drugs-Global-Market-to-2030-Identify-Growth-Segments-for-Investment.html
Two top FDA vaccine regulators RESIGN 'in fury at White House' for 'politicizing' COVID boosters by announcing third shots for all before the agency gave medical approval
https://www.dailymail.co.uk/news/article-9947445/amp/Two-FDA-vaccine-regulators-RESIGN-clashing-WH-COVID-boosters.html
But the current system for handling COVID-related claims is different – and not in a good way. Because if you’ve suffered an injury related to the Pfizer, Moderna or Johnson & Johnson vaccines, you’re basically out of luck. ———
As Renée Gentry, director of the Vaccine Injury Litigation Clinic at the George Washington University Law School put it, COVID vaccine claimants have two rights: “You have the right to file,” she said. “And you have the right to lose.”
https://www.reuters.com/legal/government/black-hole-covid-vaccine-injury-claims-2021-06-29/
Also, Moss added that many of the nurses and medical professionals are now talking about the mu variant, stating that the vaccine is even less effective against that variant of COVID-19. ———
“Sometimes, they are labeled as anti-vaxxers, and that is not really the case at all. They have had their vaccines from all the other things that were required of them at the hospital, but they have some concerns about this particular vaccine. They’re just asking that we try and delay its implementation for the mandation [sic],” said Del. Amy Summers, R–Taylor County.
https://www.wboy.com/news/health/coronavirus/wvu-medicine-employees-hold-meeting-with-local-state-leaders-regarding-covid-19-vaccination-mandate/
IF THERE IS A RISK OF HARM THERE SHOULD BE CHOICE IN THE MATTER
https://rumble.com/vmgydn-wvuh-to-require-all-employees-to-be-vaccinated-or-will-face-voluntary-termi.html
John Stokes, a Division I Athlete and Academic Medal of Honor student at Tennessee State University, is hospitalized with myocarditis after second jab. John says NCAA should not mandate student athletes get vaccinated due to the high risk of heart issues.
https://www.tiktok.com/@john.stokes/video/7005038789269802245
In the coronary arterial walls, VIP may contribute to the regulation of normal coronary vasomotor tone. In research animals and in humans, VIP, administered into the coronary artery or intravenously, increases the epicardial coronary artery cross-sectional area, decreases coronary vascular resistance, and significantly increases coronary artery blood flow. High frequency parasympathetic (vagal) nerve stimulation also releases endogenous VIP in the coronary vessels and heart and significantly increases coronary artery blood flow. In addition, the release of VIP in the heart is increased during coronary artery occlusion and during reperfusion where VIP may promote local blood flow and may have a free-radical scavenging effect. VIP also has a primary positive inotropic effect on cardiac muscle that is enhanced by its ability to facilitate ventricular-vascular coupling by reducing mean arterial pressure by 10-15%. In concentrations of 10(-8)-10(-5) mol, VIP augments developed isometric force and increases atrial and ventricular contractility. The presence of VIP-immunoreactive nerve fibers in and around the sinus and the atrioventricular nodes of mammals strongly suggests that this peptide can affect the heart rate. In this regard, endogenously released or exogenous VIP can significantly increase the heart rate and has a more potent effect on heart rate than does norepinephrine. The presence and significant cardiovascular effects of VIP in the heart suggests that this peptide is important in the regulation of coronary blood flow, cardiac contraction, and heart rate. Current investigations are defining the physiological role of VIP in the regulation of cardiovascular function.
https://www.researchgate.net/publication/12206497_Vasoactive_intestinal_peptide_Cardiovascular_effects
The global cardiovascular drugs market is expected to be around US$ 90.50 Bn by 2025 CAGR of over 1.0% from 2019 to 2025.
https://www.marketwatch.com/press-release/cardiovascular-drugs-market-share-size-growth-key-companies-cagr-status-by-2028-2021-06-07
A MULTIDIMENSIONAL BENEFIT???
February 23, NeuroRx said the Phase IIb/III COVID-AIV trial (NCT04311697) of Zyesami (aviptadil, previously RLF-100™) for the treatment of respiratory failure in critically ill patients with COVID-19 has shown multidimensional benefit around its prespecified primary endpoint of recovery from respiratory failure with discharge from hospital and ICU (without relapse) by day 28 in patients with critical COVID-19 who were treated with High Flow Nasal Oxygen. The trial was conducted at 10 U.S. hospitals under the direction of NeuroRx and its Swiss partner Relief Therapeutics.
https://www.genengnews.com/covid-19-candidates/relief-therapeutics/
The size of the COVID-19 vaccine market across the seven major markets – the US, Germany, France, Italy, Spain, the UK, and Japan -will increase from $13.6bn in 2021 to $19.5bn in 2026 at a compound annual growth rate (CAGR) of 7.6% should annual vaccination be required, according to GlobalData.
https://www.pharmaceutical-technology.com/news/covid-19-vaccine-market-set-to-reach-19-5bn-by-2026-register-for-free-webinar/
WILL INFLUENZA BE NEXT???
ARDS is predominantly an inflammatory process that can be caused by a primary or secondary trigger. Influenza acts as a primary etiology and when there is an exaggerated inflammatory response the result can be severe respiratory failure.
https://www.aarc.org/nn19-ecls-in-influenza-related-ards/
Influenza Vaccine Market to Hit USD 7.60 Billion with 6.9% CAGR by 2027; Increasing Geriatric Population to Stoke Demand: Fortune Business Insights™
https://www.globenewswire.com/en/news-release/2021/03/10/2190110/0/en/Influenza-Vaccine-Market-to-Hit-USD-7-60-Billion-with-6-9-CAGR-by-2027-Increasing-Geriatric-Population-to-Stoke-Demand-Fortune-Business-Insights.html
CAN THE BEST OF VACCINES DO THIS??? 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. VIP is known to target the VPAC1 receptor of the alveolar type II cell (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. https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic
Using RNA as the genetic material is very efficient (a single strand is easier and cheaper to make than two!), but it is also very likely to develop errors during replication relative to using double stranded DNA (like human beings use). Among other problems with this viral strategy is that this means that viruses that use RNA often mutate very fast. Good thing that human beings use DNA to store their genetic information! ————
RNA viruses make this high mutation rate work for them. The high mutation rate of RNA viruses is one reason why it is difficult to make effective vaccines against many of these types of viruses. ———-
Positive-sense RNA viruses account for a large fraction of all known human viruses, including many well-known pathogens such as HIV (the AIDS virus), hepatitis C virus (liver cancer), rhinoviruses (common cold), West Nile virus, Dengue virus, Zika, SARS and MERS coronaviruses, and COVID-19. Even though the single stranded RNA strategy comes with the problem of high mutation rate, these viruses replicate so efficiently, and produce so many viruses so fast, that it does not slow them down. In fact, the high mutation rate is sort of an advantage for viruses- it makes it easy for them to evolve and adapt to a new host (you and me) very rapidly, and to adapt to escape immunity in the animals that they infect (including us). ————
There have been reports of the virus’ genome being different at various time points within an individual. Another RNA virus with this capability that we are all familiar with is HIV. ————
(For those of you paying attention, smash these ideas together with 1) escape mutants against a vaccine with a target of a single protein (spike in this case) and 2) why we don't have a vaccine for HIV and the common cold...)
https://www.rwmalonemd.com/news
WHAT DOES SWEDEN KNOW THAT WE DON’T? ~ RW Malone MD ————
Sweden also banned the entry of citizens from the United States, Kosovo, Lebanon, Montenegro, and North Macedonia. ————
Interior Minister Mikael Damberg told news outlets that the sharp increases in COVID-19 cases in Israel, the United States, and other countries are the reason why they were removed from Sweden’s travel ban exemption. Despite Israel’s mass vaccination campaign, the virus has continued to spread, Damberg said. ————
According to a news release from the Swedish government, it will reintroduce a travel ban on Israel, the U.S., and other countries starting from Sept. 6. ————
https://www.theepochtimes.com/sweden-bans-travelers-from-israel-one-of-the-most-vaccinated-nations_3978811.html
Measles Cases Bring Temporary Halt to Afghans’ Arrival in U.S. ————
The C.D.C. asked that the evacuation flights from overseas bases be suspended after four Afghans were found to be infected.
https://www.nytimes.com/2021/09/10/us/politics/measles-afghanistan-refugees.html
The pathogen. The measles virus is a single-stranded RNA virus of the genus Morbillivirus and the family Paramyxoviridae. The virus is related to several viruses that infect animals, including the Canine Distemper Virus.
https://www.ecdc.europa.eu/en/measles/facts
The virus crosses the blood-brain barrier and enters the brain in around 1 in 1,000 people. This can cause swelling in the brain that may be life-threatening. An infection in the lungs causes a person to cough, which transmits the virus to other people. ————
**Rash: yes: itchy red rash that eventually forms blisters
Contagious period: up to two days until rash develops and then until spots scab over
**Lesions in mouth: yes: blisters can form in the mouth
https://www.medicalnewstoday.com/articles/37135
On February 23, NeuroRx said the Phase IIb/III COVID-AIV trial (NCT04311697) of Zyesami (aviptadil, previously RLF-100™) for the treatment of respiratory failure in critically ill patients with COVID-19 has shown multidimensional benefit around its prespecified primary endpoint of recovery from respiratory failure with discharge from hospital and ICU (without relapse) by day 28 in patients with critical COVID-19 who were treated with High Flow Nasal Oxygen. The trial was conducted at 10 U.S. hospitals under the direction of NeuroRx and its Swiss partner Relief Therapeutics. https://www.genengnews.com/covid-19-candidates/relief-therapeutics/ NRx Pharmaceuticals has reported additional data from Phase IIb/III clinical trial where its drug, Zyesami (aviptadil), offered a rise in blood oxygen within a day in critical Covid-19 patients with acute respiratory failure. Zyesami is a synthetic form of vasoactive intestinal polypeptide (VIP), which attaches selectively to the alveolar type II cell (ATII) in the air sac (alveolus) of the lung. The latest analysis results showed that subjects receiving Zyesami had improvement in blood oxygen, which signifies improved lung function, within a day of commencing therapy. … “The benefit was seen across all patients, all baseline severities, and all types of hospitals. “We believe this new finding illustrates Zyesami’s mechanism of action in a placebo-controlled trial and supports our application for breakthrough therapy designation to the FDA.” https://www.pharmaceutical-technology.com/news/nrx-zyesami-covid-trial/
Gain of function research includes any research that makes viruses more transmissible and more deadly. According to the document obtained by The Intercept the NIH was specifically funding GOF to spike the gene of one coronavir...
https://trialsitenews.com/the-intercept-document-dump-reveals-troubling-evidence-of-gof-research-did-dr-anthony-fauci-lie-to-congress/
DRUG LOBBY ASKS BIDEN TO PUNISH FOREIGN COUNTRIES PUSHING FOR LOW-COST VACCINES ———
Big Pharma is fighting for tight control over Covid-19 vaccine production, limiting availability worldwide while reaping billions.
https://theintercept.com/2021/03/03/vaccine-coronavirus-big-pharma-biden/
What if all of the assumptions that people are making about this COVID pandemic are completely wrong? When Pfizer announced that they had developed a successful vaccine for COVID, the world cheered. And then when Moderna announced that they had developed a successful vaccine for COVID, the world cheered even more. But COVID has been mutating, and scientists assure us that it will keep mutating. So what happens if the vaccines that are being developed end up being completely useless against new mutant strains of the virus? Would that put us all the way back to square one (or even worse)?
https://www.zerohedge.com/medical/new-strains-covid-could-render-vaccines-completely-useless-and-2-dangerous-mutations-are
WHAT SIDE EFFECTS???
https://medicalkidnap.com/2021/08/18/censored-covid-vaccine-injured-who-regret-their-decisions-to-get-the-shot-and-their-message-to-you/
Dr Malone asks why health leaders seem to be so afraid of sharing the adverse event data. He says, "Why is it necessary to suppress discussion and full disclosure of information concerning mRNA reactogenicity and safety risks?"
He goes onto say that we should be analysing the safety data and risks vigorously. Again he asks, "Is there information or patterns that can be found, such as the recent finding of the cardiomyopathy signals, or the latent virus reactivation signals? We should be enlisting the best biostatistics and machine learning experts to examine these data, and the results should- no must- be made available to the public promptly". ————
For any drug it has always been important to have systems in place for monitoring adverse events. However, for an experimental, genetic modifying approach that has not been fully tested, and where the public are effectively the guinea pigs, this information should be immediately and readily available. As previously reported in Total Health, the fact that it is so difficult to access and make sense of the US VAERS, and UK Yellow Card reporting systems - along with low reporting simply raises further concern about what is actually happening.
https://www.totalhealth.co.uk/blog/are-people-getting-full-facts-covid-vaccine-risks
VITAL ORGANS??? ———
These are the brain, heart, kidneys, liver and lungs. The human brain is the body's control center, receiving and sending signals to other organs through the nervous system and through secreted hormones.
https://www.livescience.com/37009-human-body.html
DOES VIP HAVE YOU COVERED???
Using Northern blotting, VPAC1 is localized to lung > prostate > peripheral leukocyte, liver, brain, small intestine > colon, heart, spleen > placenta, kidney, thymus, testis (decreasing order of expression). By receptor autoradiography, VPAC1 is expressed in many epithelial cells, such as hepatocytes, mucosal cells of the stomach and colon, acinar and/or duct cells of the breast, pancreas, and lung, and glandular cells of the thyroid, prostate, uterus, and adrenal medulla.
https://www.sciencedirect.com/topics/neuroscience/vasoactive-intestinal-polypeptide-receptor-1
CAN THE BEST OF VACCINES DO THIS???
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.
VIP is known to target the VPAC1 receptor of the alveolar type II cell (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.
https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic
On February 23, NeuroRx said the Phase IIb/III COVID-AIV trial (NCT04311697) of Zyesami (aviptadil, previously RLF-100™) for the treatment of respiratory failure in critically ill patients with COVID-19 has shown multidimensional benefit around its prespecified primary endpoint of recovery from respiratory failure with discharge from hospital and ICU (without relapse) by day 28 in patients with critical COVID-19 who were treated with High Flow Nasal Oxygen. The trial was conducted at 10 U.S. hospitals under the direction of NeuroRx and its Swiss partner Relief Therapeutics.
https://www.genengnews.com/covid-19-candidates/relief-therapeutics/
NRx Pharmaceuticals has reported additional data from Phase IIb/III clinical trial where its drug, Zyesami (aviptadil), offered a rise in blood oxygen within a day in critical Covid-19 patients with acute respiratory failure.
Zyesami is a synthetic form of vasoactive intestinal polypeptide (VIP), which attaches selectively to the alveolar type II cell (ATII) in the air sac (alveolus) of the lung.
The latest analysis results showed that subjects receiving Zyesami had improvement in blood oxygen, which signifies improved lung function, within a day of commencing therapy.
…
“The benefit was seen across all patients, all baseline severities, and all types of hospitals.
“We believe this new finding illustrates Zyesami’s mechanism of action in a placebo-controlled trial and supports our application for breakthrough therapy designation to the FDA.”
https://www.pharmaceutical-technology.com/news/nrx-zyesami-covid-trial/
NRXP, GOING FOR THE GOLD??? ———
NRx Pharmaceuticals Announces New Finding from ZYESAMI™ (aviptadil) Phase 2b/3 Clinical Trial Demonstrating Clinically Significant Relief from Respiratory Distress in Critical COVID-19
https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-announces-new-finding-from-zyesami-aviptadil-phase-2b3-clinical-trial-demonstrating-clinically-significant-relief-from-respiratory-distress-in-critical-covid-19-301365091.html
NeuroRx Receives FDA Breakthrough Therapy Designation for NRX-101, First Oral Drug Targeting Suicidal Bipolar Depression
https://www.businesswire.com/news/home/20181113005407/en/NeuroRx-Receives-FDA-Breakthrough-Therapy-Designation-for-NRX-101-First-Oral-Drug-Targeting-Suicidal-Bipolar-Depression
The Real Value Of A Breakthrough Therapy Designation
Summary
——— Average approval time reduced by 2.5-3.5 years.
——— Breakthrough therapy designation usually increases valuation significantly.
——— Takeover offers typically increase with breakthrough therapy designations.
——— Takeover offers for a company with 2 breakthrough therapy designations increase significantly and quickly.
——— Evaluating high flyers and value companies.
https://seekingalpha.com/article/4314267-real-value-of-breakthrough-therapy-designation
ROLLUP, EUA or NEW DRUG APPROVAL??? ———
New NRXP Update:
——— Sept 4, 2021 ———
CEO Update: Ongoing ———Communications with the US Food and Drug Administration ———
NRx Pharmaceuticals continues to receive many requests for updates on the status of the US Food and Drug Administration’s (FDA) review of NRx’s application for Emergency Use Authorization (EUA) of ZYESAMI™ (aviptadil), to treat patients suffering from Critical COVID-19 with respiratory failure. ———
On September 3, 2021, NRx received a request for additional clinical information from the FDA, and plans to respond to this information request within a week. Ongoing conversations between the FDA and sponsor of any application to the FDA are normal, expected, and important to the FDA’s review process. ———
NRx has responded to three prior information requests since filing the EUA application on May 31, 2021. FDA’s review of NRx’s EUA application remains ongoing ———
This is the process of FDA therapeutic drug approval. Patience is going to pay us very well. ~ Zaran, Y@h00 RLFTF finance conversations >>>
NO PRESSURE???
Read this from the new sec file from 4. of September. This is huge:
"We filed for EUA for ZYESAMI on May 31, 2021 with the FDA and shortly thereafter with the Ministry of Health of the Nation of Georgia based on the results of these trials. Approval in Georgia is expected to provide market access to surrounding Caucasus region countries with a combined population of more than 100 million people." ~ Nick, Y@h00 RLFTF finance conversations >>>
NRx Pharmaceuticals to Work with Cardinal Health to Ensure Efficient Distribution of Potential Therapies ———
—- Agreement Represents Path to Market for ZYESAMI™, as Time to Treatment is Crucial for Patients
—- Cardinal Health Third Party Logistics Services to Provide Logistical and Distribution Support for ZYESAMI™ (aviptadil) Upon Potential FDA Approval
—- Cardinal Health Specialty Pharmaceutical Distribution to Serve as the Exclusive Distributor to Ensure Access to ZYESAMI™ (aviptadil) Upon Potential FDA Approval
https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-to-work-with-cardinal-health-to-ensure-efficient-distribution-of-potential-therapies-301363293.html
DOES RLFTF HAVE GOOD REASON TO ACCELERATE???
By acquiring the rights to AdVita’s therapy formulation, Relief also will accelerate and secure RLF-100’s future development as an inhaled therapy for lung diseases, such as pulmonary sarcoidosis, that are associated with COVID-19. Other lung diseases associated with COVID-19, which also could potentially be treated by RLF-100, include checkpoint inhibitor-induced pneumonitis, and acute respiratory distress syndrome (ARDS).
https://sarcoidosisnews.com/2021/01/28/deal-gives-relief-therapeutics-intellectual-rights-potential-sarcoidosis-therapy-rlf-100/
This study is the first to show the immunoregulatory effect of VIP in humans, and supports the notion of inhaled VIP as an attractive future therapy to dampen exaggerated immune responses in lung disorders. Thus, the inhalation of neuropeptides may be developed into a new therapeutic principle for chronic inflammatory lung disorders in humans.
https://pubmed.ncbi.nlm.nih.gov/20442436/
There is mounting evidence that pulmonary arterial hypertension (PAH), asthma and chronic obstructive pulmonary disease (COPD) share important pathological features, including inflammation, smooth muscle contraction and remodeling. No existing drug provides the combined potential advantages of reducing vascular- and bronchial-constriction, and anti-inflammation.
https://respiratory-research.biomedcentral.com/articles/10.1186/1465-9921-12-45
Zyesami(TM) and RLF-100 are basically the same Aviptadil compounds.
NeuroRx Zyesami(TM) is going after COVID-19 EUA, Breakthrough Therapy, and ultimately FDA approval.
If Zyesami(TM) gets EUA or FDA Approval and since we are the same Aviptadil compound, does RLF-100 also gets FDA Approval? Does RLF-100 have a shelf life of a year or longer? Can RLF-100 be scaled up to 100,000 doses per manufacturing batch to a projected 3 million doses per batch? Do RLF-100 have a distribution system in place? Seems to me NeuroRX Zyesami(TM) has been showing RLFTF the steps/strategy to imminent COVID-19 EUA and/or FDA Approval in the USA and worldwide.
https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic
As Dr. Javitt once stated, if we handle the ARDS killer in COVID-19 the patient is left with a bad cold and there are therapeutics for bad colds.
Anaphylaxis is a severe, potentially life-threatening allergic reaction. It can occur within seconds or minutes of exposure to something you're allergic to, such as peanuts or bee stings.
Anaphylaxis causes your immune system to release a flood of chemicals that can cause you to go into shock — your blood pressure drops suddenly and your airways narrow, blocking breathing. Signs and symptoms include a rapid, weak pulse; a skin rash; and nausea and vomiting. Common triggers include certain foods, some medications, insect venom and latex.
https://www.mayoclinic.org/diseases-conditions/anaphylaxis/symptoms-causes/syc-20351468
Being crucial signal molecule of the neuroendocrine-immune network, the development of stable VIP analogue and/or antagonist may provide the future therapeutic drug alternative for the better treatment of these allergic diseases. Taken together, our current review summarizes the current understandings of VIP biology and further explore the significance of neuroendocrine cells derived VIP in the recruitment of inflammatory cells in allergic diseases that may be helpful to the investigators for planning the experiments and accordingly predicting new therapeutic strategies for combating allergic diseases.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5705463/
The anaphylaxis treatment market is expected to reach US$ 4,787. 66 million in 2028 from US$ 2,664. 66 million in 2021; it is estimated to grow at a CAGR of 8.
https://www.globenewswire.com/news-release/2021/08/30/2288398/0/en/Anaphylaxis-Treatment-Market-Forecast-to-2028-COVID-19-Impact-and-Global-Analysis-By-Medication-Type-Route-of-Administration-Allergy-Type-and-Distribution-Channel.html
Jul 20, 2021 (The Expresswire) -- The global asthma treatment market size is expected to reach USD 26.01 billion by 2027, exhibiting a CAGR of 4.5% during the forecast period.
https://www.marketwatch.com/press-release/asthma-treatment-market-size-to-touch-usd-2601-billion-with-45-cagr-by-2027-global-market-share-trends-growth-and-analysis-2021-07-20
The global allergy diagnostics and therapeutics market size is expected to reach USD 51.95 billion by 2026 registering a CAGR of 6.3%, according to a new study by Grand View Research, Inc.
https://www.grandviewresearch.com/press-release/global-allergy-diagnostics-therapeutics-market
Antibody-Dependent Enhancement
A major concern of doctors and scientists is whether the vaccines are creating resistant variants, a phenomenon known as antibody dependent enhancement (ADE), when antibodies do not stop the virus from entering a cell but increase its ability, like a Trojan horse.
In an August 21 article in NOQ Report , Dr. Joel Hirschhorn reviews warnings made months ago from two top virologists: Dr. Luc Montagnier, a Nobel laureate, and Dr. Vanden Bossche, who is on the faculty of universities in Belgium and Germany and has worked in the pharmaceutical industry.
https://heartlanddailynews.com/2021/08/data-suggests-government-is-making-pandemic-worse-not-better/
What are the long-term effects of coronavirus infection?
According to the CDC, the most common lasting symptoms are fatigue, shortness of breath, cough, joint pain and chest pain. Other issues include cognitive problems, difficulty concentrating, depression, muscle pain, headache, rapid heartbeat and intermittent fever.
Breathing issues after COVID-19
A bad case of COVID-19 can produce scarring and other permanent problems in the lungs, but even mild infections can cause persistent shortness of breath — getting winded easily after even light exertion.
Lung recovery after COVID-19 is possible, but takes time. Experts say it can take months for a person’s lung function to return to pre-COVID-19 levels. Breathing exercises and respiratory therapy can help.
https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/covid-long-haulers-long-term-effects-of-covid19
CAN THE BEST OF VACCINES DO THIS??? ——— 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.
VIP is known to target the VPAC1 receptor of the alveolar type II cell (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.
https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic
RADNOR, Pa., Aug. 30, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (Nasdaq: NRXP) announced an additional finding in its phase 2b/3 clinical trial investigating ZYESAMI™ (aviptadil) for the treatment of patients with acute Respiratory Failure due to Critical COVID-19. Previously announced results have focused on survival and recovery from respiratory failure at 60 days, and ZYESAMI's apparent role in preventing rise in the inflammatory cytokine IL-6, known as "Cytokine Storm."
NRx's new analysis shows that patients treated with ZYESAMI demonstrated improvement in blood oxygen, indicative of improved lung function, within a day of starting treatment. The average difference in Respiratory Distress Ratio between those treated with aviptadil and placebo was both clinically meaningful and statistically significant. Moreover, the difference is comparable to that reported a year ago from an open label study at Houston Methodist Hospital by Dr. J Georges Yousef.
https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-announces-new-finding-from-zyesami-aviptadil-phase-2b3-clinical-trial-demonstrating-clinically-significant-relief-from-respiratory-distress-in-critical-covid-19-301365091.html
My two cents about the disclaimer and the Relief response to @Mav's email.
I personally would not draw any conclusions from the emailed reply.
I have a company with three friends and from my 10-year experience as a director the one thing I am absolutely certain is true worldwide is that what goes out can never contradict the official line otherwise you paint a terrible image to your investors, bankers, and you run foul of your lawyers.
At the moment the latest NRx SEC filings imply a refusal by Relief to go beyond what they are contractually meant to pay, something which is stated very clearly in the same filings : "it is NRx responsibility not to exceed 30% over budget".
So, purely from a financial point of view, there is actually no dispute any more - it was interesting to read the change of wording in the latest filing compared to the filings earlier this year which riled up Relief and got them to issue their own PR. The latest filings clearly point out that Relief has paid 10.9 million, $100K over the over-budget, there is still a loan that NRx is paying back to Relief until April, and what is made very clear in those filings is that Relief have paid everything they were meant to pay, even the 30% over-budget.
Moving over to the other points of contention : data and patents. Relief has all the patents and covers all formulations, whether intravenous (Mondobiotech) or inhaled as per Advita's worldwide patent of 5th August.
With regards to the data, I go back to my first point : lawyers.
As per my last post 10 days ago or so, I believe that behind the scene the $30 million direct placement that HC Wainwright negotiated exclusively for NRx had some heavy input by you know who and that informal behind the scenes discussions between NRx, Ram, and GEM would have put some conditions on that $30 million. That $30 million placement would never have happened any other way.
Problem : until future NRx SEC filings and/or lawyer verified statements from NRx, and a variety of other legal statements, all answers to an email from us retail investors will come back with statements identical to the Relief disclaimer at the bottom of their Press Release on Monday.
I personally am not losing ANY sleep on this whatsoever : in this game of poker the Relief's hand is in full view of everyone and is loaded with all four aces. ~ Ilka, Y@h00 RLFTF finance conversations
APPROVED??? On October 22, 2020, FDA approved Veklury (remdesivir) for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. ~ FDA
https://www.fda.gov/drugs/drug-safety-and-availability/fdas-approval-veklury-remdesivir-treatment-covid-19-science-safety-and-effectiveness
Remdesivir’s approval was based on a Phase 3 study run by the National Institute of Allergy and Infectious Diseases, which concluded that the drug shortens recovery time for hospitalized COVID-19 patients by a few days. Yet interim results from a World Health Organization study suggest that remdesivir has no benefits.
https://cen.acs.org/pharmaceuticals/drug-discovery/Is-drug-repurposing-worth-the-effort/99/i3
ONCE GRANTED FAST TRACK DESIGNATION BY THE FDA ——— They said aviptadil is shown as the first COVID therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes while also preventing synthesis of cytokines in the lung. It is a patented formulation of aviptadil (synthetic human Vasoactive Intestinal Polypeptide, VIP), which has been granted FDA fast track designation, FDA emergency use IND authorisation, and an expanded access protocol.
https://www.reuters.com/article/us-health-coronavirus-relief-hldg-idUSKCN2520ED
IF BREAKTHROUGH THERAPY DESIGNATION IS GRANTED WHAT THEN, EXPEDITED APPROVAL???
Fast track and breakthrough therapy are the most similar programs designed to expedite the development of drugs for serious conditions, so it’s easy to get the two mixed up. The most significant difference in these two programs is related to the type of data needed to substantiate the request. Fast track can be granted based on preliminary data, such as activity in a nonclinical model or pharmacological data, or a mechanistic rationale. Breakthrough therapy must use preliminary clinical data, and therefore activity in a nonclinical model or a mechanistic rationale alone would not be sufficient.
https://www.propharmagroup.com/blog/fda-expedited-approvals/
Good day Ms Pegs1, looking forward to Dr Joey Johnson’s next video to be released this weekend. Best
It's unbelievable that my post from this morning merely updating everyone about my video for this weekend, and then giving praise to how awesome this board is would get taken down! Anyway, I was able to read some of the comments first, and thank you for all who did! ———
I'll leave one more additional nugget I just found: according to this Congress Report I'm looking at right now, Cardinal Health just finished with their Gov. contract for $15 million from the U.S. Govt this month. They signed a 12-month contract last August for that amount to supply 500 million syringe vials for the vaccines to all the hospitals nationwide! ———
In other words, Dr. JJ is messing with the right upscale facilities! These are already COVID-19 working facilities that are preferred by our own US Gov! Not just approved already, but preferred! I'm seeing a pattern here where the Gov seems to be assisting us with guidance behind the scenes, IMHO. Or, Dr. JJ deserves a LOTTA credit for his business skills but it's one or the other and either way I'm like it....A LOT! ~ Joey/Y@h00 RLFTF finance conversations
“This partnership creates an efficient and highly flexible logistics and distribution model for NRx. Cardinal Health’s expertise will enable ZYESAMI to quickly reach patients in the intensive care units, as limiting the time to treatment is crucial. This also allows NRx to continue focusing on answering requests from the FDA in support of our application for Emergency Use Authorization for ZYESAMI.” — Robert Besthof, Head of Operations and Chief Commercial Officer of NRx
https://pulse2.com/nrx-pharmaceuticals-nasdaq-nrxp-stock-over-16-increase-explanation/
“As the COVID-19 pandemic continues, so does the need for more innovative, effective and FDA-approved therapies for critically-ill patients with respiratory failure. Cardinal Health is pleased to ensure that COVID-19 patients get access to treatment in a timely and efficient manner.” — Marc DeLorenzo, Senior Vice President of Strategic Sourcing at Cardinal Health ——— Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.
Correction: Expanded Access Protocol
Emergency Access Protocol ——— Have a friend on a ventilator with covid. Otherwise healthy 59 year old male. I’m sure this has been asked. Where or can he access Zyesami? ———
while it is easier to get it when the patient is on a vent or ECMO, be prepared to get total resistance from the doctor. dont NOT try to go through your doctor, you have to get neurorx on board first directly, your doctor will say no a hundred times. once neurorx is committed to getting it to you, the doctor will still resist. the hospital has to have a board meeting for every patient that gets an eIND drug, thats the protocol, and the doctor has to fill out reams of paperwork....thats why they have no desire to go down this road...dont take no for an answer, especially if neurorx has committed ———
good luck, its doable —————
Contact Robert E Besthof at NeuroRx. He is the person in charge of this. I have been fortunate to talk with him and have some very minor contact with Dr. Javitt who referred me to Mr. Besthof. The company is working with people through the Right to Try federal law. it is the fastest way to get the drug to the patient. ————
After reading this question many times, I believe the best option is to contact Neurorx directly. Ive read that they are responsive and that dr JJ sometimes helps if the hospitals/doctors are giving you a hard time
https://www.nrxpharma.com/contact-us/
good luck! ~ Y@h00 RLFTF finance conversations