BRONX, N.Y., May 21, 2020 /PRNewswire-HISPANIC PR WIRE/ -- Montefiore Health System and Albert Einstein College of Medicine are the first sites in the nation to begin evaluating an investigational drug in two separate, FDA-approved trials: one to treat mild-to-moderate cases of COVID-19, and the other to treat severely ill COVID-19 patients. 2. Assuming this rate started kicking in at the beginning of the year that is over 1000 more patients that have taken leronlimab. Encouraged by Leronlimab's efficacy, Dr. Seethramraju and his colleagues at Montefiore and Albert Einstein, in collaboration with CytoDyn and other medical researchers such as Dr.Dhody and Dr.Yang received approval from the FDA to conduct a Phase 2 double blinded trial of Leronlimab for mild to moderate symptoms of COVID-19 with an The advanced clinical and translational research at its medical school, Albert Einstein College of Medicine, directly informs patient care and improves outcomes. What matters is meeting the endpoints and reaching statistical significance. While it seems almost a prerequisite that management knows just how well the drug did, they are keeping the final data under wraps until they can negotiate the best path forward with multiple regulatory agencies. From the Montefiore-Einstein Centers of Excellence in cancer, cardiology and vascular care, pediatrics, and transplantation, to its preeminent school-based health program, Montefiore is a fully integrated healthcare delivery system providing coordinated, comprehensive care to patients and their families. These are also the investors that should know that when a drug company files their BLA there is a 99% probability of approval assuming it has a good safety profile. Anything can happen in a clinical trial but there were 45 deaths midway and then 87 right toward the end of the trial. So investors need to take solace in knowing that the biomarkers and scores really don’t matter. “The results demonstrate that CCR5 blockade by leronlimab given as a weekly subcutaneous injection in mild-to-moderate COVID-19 patients is reasonably safe and associated with rapid improvement in viral symptoms with fewer adverse events than when compared to placebo,” lead principal investigator Harish Seethamraju, MD, of the Montefiore Medical Center in New York, said in a statement. His tweet was just 16 minutes after CYDY’s press release and insinuated that SEC regulators should suspend trading in the stock of CYDY for not disclosing material information to shareholders. Investors have the choice of believing statistics or believing the conjecture of a tabloid blogger who moonlights as a biotech analyst. CytoDyn Inc. (OTMKTS: CYDY) announced discussions with 3 regulatory agencies after an unblinding of the data on February 22, 2021, and the price fell precipitously on the open primarily due to a tweet by the Night King of Biotech known as Adam Feuerstein. For over five years, we have provided a free service to a countless number of traders featuring only the best in the microcap arena. Patients will be randomized to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. So it’s understandable why Feurerstein lashed out the way he did with little to no basis for his tweet. It is absolutely amazing he still has a job after a scandal that could land him in court, but that’s just par for the course in the tabloid business. What is so interesting  is that the DSMC added a new endpoint of 42 day survival the last time they looked at the data so if that was a factor in the study it would be nullified. spam. We hate The data in Dr. Yang’s UCLA study demonstrated a very low mortality rate of 23% in very sick critical care patients. Although there was no control group this cohort of people was much sicker than any of the controlled trials, and put up numbers envious of most drug candidates. What CEO would be eager to discuss bad data? “Such patients all too often seem to be recovering, but then crash and burn when their lungs are overwhelmed by an inflammatory reaction that makes breathing impossible, “says Dr. Seethamraju. On April 16th, Montefiore enrolled the first patient in a second FDA-approved leronlimab clinical trial: a randomized, double blind trial to assess the optimal dose, safety and effectiveness of leronlimab in treating severely ill COVID-19 patients. Typically it’s smart play to stay on the FDA’s good side, so it’s completely in line with expectations that Nader would choose to keep partially analyzed data out of the public domain to avoid any corrections later one that could potentially cast doubt on the credibility well after the data was thoroughly analyzed. It’s very possible that the standard of care (SOC) improved so much that it pushed the median survival of these severe to critical patients further out in time. A total of 75 will participate. There was statistically relevant mild to moderate data that showed a reduction in the NEWS2 score. Published … The first trial being applied for is to study the leronlimab in patients with mild to moderate COVID-19 respiratory symptoms. “The FDA is concerned that there is no treatment for those people.”. There is more to the story here and it gets better because there could be a supportive OLE trial that helps support the readout. , and the price fell precipitously on the open primarily due to a tweet by the Night King of Biotech known as Adam Feuerstein. A straw poll of doctors using leronlimab under OLE revealed there was extremely high demand to get into the trial. The power that Feuerstein’s words have over common sense are baffling. It has been about a month and if they were recruiting at the rate of 20 per day when they stopped the OLE might be higher. The reason missing the primary endpoint is no big deal is that even though this is a secondary endpoint it’s a mortality endpoint and if they find statistical significance in any survival number at any point during the disease the drug will be a shoe in for approval. Cytodyn’s press release completely derisked the approval process. Its also important to note that the Montefiore patients all failed hydroxychloroquine and remdesivir before trying leronlimab. El 16 de abril, Montefiore inscribió al primer paciente en el segundo ensayo clínico de leronlimab aprobado por la FDA: un ensayo aleatorizado, doble ciego para evaluar la dosis óptima, la seguridad y la eficacia del leronlimab en el tratamiento de pacientes con COVID-19 gravemente enfermos. The 390 patients taking part in this multicenter trial will receive two weekly doses of either leronlimab or a placebo; there will be twice as many patients receiving leronlimab as those receiving the placebo. A delay in announcing top line results was expected. … A clean win means a drug that meets the primary endpoint with statistical relevance and no modification of its endpoint after the trial starts. Dr. Seethamraju is a co-principal investigator of the Montefiore trial site, along with Scott A. Scheinin, M.D., surgical director of advanced pulmonary failure and lung transplantation, division chief of thoracic surgery and surgical oncology, and director of the Bloodless Heart Surgical Program at Montefiore. There was statistically relevant mild to moderate data that showed a reduction in the NEWS2 score. Since the start of COVID-19, not one drug has had a clean win in topline data. In this situation whether they met the endpoint or crushed it doesn’t really matter because the ultimate goal is an approval. Leronlimab is a monoclonal antibody drug developed by CytoDyn Inc., a biotechnology company based in Vancouver, WA. There is clearly a benefit of the drug whether it is in the enormous reduction of SAEs, the NEWS2 index that shows the reduction of stress on COVID-19 patients, the reduction in the number of people going on ventilators, or the reduction in the total symptom score. The reason missing the primary endpoint is no big deal is that even though this is a secondary endpoint it’s a mortality endpoint and if they find statistical significance in any survival number at any point during the disease the drug will be a shoe in for approval. In this situation whether they met the endpoint or crushed it doesn’t really matter because the ultimate goal is an approval. In addition, investors should expect a cluster bomb of wins on the secondary endpoint. On April 16th, Montefiore enrolled the first patient in a second FDA-approved leronlimab clinical trial: a randomized, double blind trial to assess the optimal dose, safety and effectiveness of leronlimab in treating severely ill COVID-19 patients. BRONX, N.Y., May 21, 2020 /PRNewswire/ -- Montefiore Health System and Albert Einstein College of Medicine are the first sites in the nation to begin evaluating an investigational drug in two separate, FDA-approved trials: one to treat mild-to-moderate cases of COVID-19, and the other to treat severely ill COVID-19 patients. When it comes to the doctor from Montefiore, the top Alzheimer doctor in the world, calls me and says that "I've been looking at leronlimab very carefully". Harish Seethamraju, M.D., an organ transplant specialist and a member of the department of medicine at Montefiore and Einstein, researched leronlimab early in the pandemic, and realized its potential for treating his transplant patients who had COVID-19. The mortality rate in the SOC was 35.8% versus 28% for Actemra and 22.2% for Kevzara. Here is the quote from CEO Nader Pourhassan, “We are eager to reach a conclusion in our discussions with all the regulatory agencies for the path going forward and will release the details of our data and the results of our discussions with regulatory agencies in the coming weeks.”, Pourhassan’s one sentence statement needs to be parsed extremely carefully. This is his pattern of wretched behavior, which has earned him the scorn of countless investors. Follow us on Twitter and view us on Facebook and YouTube. Investors should be betting on approval, and not Adam Feuerstein’s foul analysis. 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