Here Today
2 years ago
Not over yet since the FDA May allow with some provisions. Adcom an advisory and not a final decision. Letโs see what happens since I believe as the Wednesday company PR states:
Veru Provides Update on FDA Advisory Committee Meeting Regarding Emergency Use Authorization of Sabizabulin to Treat Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome
MIAMI, FL, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, announces the results of todayโs meeting of the U.S. Food and Drug Administrationโs (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC), which reviewed sabizabulin for Emergency Use Authorization (EUA) in hospitalized moderate to severe COVID-19 patients who are at high risk for acute respiratory distress syndrome (ARDS). The advisory committee voted 8-5 that the known and potential benefits of sabizabulin when used for the treatment of adult patients hospitalized with COVID-19 at high risk of ARDS do not outweigh the known and potential risks of sabizabulin. However, there was additional discussion around the clinical trial design aspects of an additional clinical trial as a potential post authorization requirement. FDA will consider the input of the advisory committee as part of their review of the EUA and render a decision on the Emergency Use Authorization.
โWe look forward to continuing to work with the FDA as we continue our efforts to ensure that this product is available to patients in a timely manner,โ said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru.
โIn a still evolving COVID-19 pandemic taking the lives of over 300 U.S. citizens a day and with the threat of new virus variants looming that may not be as easily treated with the limited array of presently used therapies, there is an urgent need for newer therapies with much greater effectiveness than what is available. Sabizabulin with its unique action as a microtubular disruptor, both reducing inflammation and viral replication independent of virus variant, shows compelling promise,โ said Erik Swenson, M.D. Professor of Medicine, Physiology, and Biophysics, University of Washington, and former Chairman of PADAC. โIn a recently published well-executed double-blind placebo-controlled trial of patients with respiratory compromise and at high risk of developing ARDS, sabizabulin reduced absolute mortality at 60 days by 20.5%, compared to 0-6% for all other available drugs. In the long history of drug trials for patients with severe respiratory failure over many decades, there has never been a drug to show such dramatic protection.โ
โAdding sabizabulin to the cadre of therapies among hospitalized patients with COVID-19 is crucial in the effort to reduce mortality among a group of patients who have seen the least reduction in death despite newer treatments and approaches,โ said Christian Sandrock, M.D. Division Vice Chief of Internal Medicine and Director of Critical Care University of California, Davis, School of Medicine.
Phase 3 sabizabulin clinical study:
A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in 204 hospitalized COVID-19 patients with moderate to severe COVID-19 at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Based on a planned interim analysis of the first 150 patients randomized, the Independent Data Monitoring Committee unanimously halted the study for clear clinical efficacy and no safety concerns were identified. Treatment with sabizabulin 9 mg once daily, an oral, first-in-class, new chemical entity, microtubule disruptor that has dual anti-inflammatory and antiviral properties, resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths compared to placebo. In the full study, there were 204 patients enrolled, and for the primary endpoint, there was a clinically meaningful and statistically significant 20.5% absolute reduction and 51.6% relative reduction in mortality at Day 60. In June, the Company submitted a request for Emergency Use Authorization to FDA. On July 6, 2022, the Company announced the publication of the Phase 3 COVID-19 trial results evaluating the efficacy and safety of oral sabizabulin in The New England Journal of Medicine Evidence®.
Global regulatory activities:
The UKโs Medicines and Healthcare Products Regulatory Agency (MHRA) informed the Company on July 25, 2022, that the sabizabulin marketing authorization application will receive expedited review. On July 27, 2022, The European Medicines Agencyโs Emergency Task Force initiated the review of sabizabulin treatment for hospitalized COVID-19 patients for emergency use in European Union countries. On August 22, 2022, Australiaโs Therapeutic Goods Administration (TGA) determined that sabizabulin treatment in hospitalized COVID-19 patients at high risk for ARDS qualifies for an expedited, provisional registration regulatory pathway.
rwwest
2 years ago
Oppenheimer analyst Leland Gershell maintains Veru, Inc. at Outperform with a price target of $36.00, following a recent FDA AdComm vote.
(from a post on yhoo)
Veru (VERU): "See EUA More Likely Than Not " - Oppenheimer Reiterates Stock at Outperform, $36 PT, November 10, 2022 6:30 AM EST
The analyst comments: "At face value, yesterday's advisory committee vote of 5 yes, 8 no to the single voting question of whether sabizabulin's benefits outweigh its risks in those hospitalized with COVID-19 at high risk of ARDS may be taken by some as fait accompli that the FDA will deny VERU's EUA request. Irrespective of their individual votes, all the panel members were favorable on the drug's potential utility and expressed appreciation for the considerably limited amount of efficacy, safety, and mechanistic understanding on sabizabulin, as well as the potential for various aspects of the Phase 3 trial to have biased its outcome. We believe the key distinction between those who voted "yes" vs. "no" was the standard against which this unique case was measuredโa standard that may have been unreasonably stringent in the minds of the "no" voters, as the Phase 3 was conducted during a critical/chaotic period of the pandemic in which more ideal trial conditions simply may not have existed.
We believe the most reasonable course of regulatory action will be that which the briefing documents appeared to lay out, that is, for the FDA to authorize sabizabulin for emergency use in the Phase 3 population (WHO 5 and 6, or WHO 4 with comorbidities) and, as a condition of such, stipulate that VERU conduct another randomized double-blind trial in the same population in which patients are fully matched with respect to baseline characteristics and evaluates sabizabulin for superiority to placebo on top of standard of care."
Alleyba1
2 years ago
Alleyba1
In my opinion, Dr. Mario Eisenbarger, who was an insider of the company (I believe), sold his entire stake in this company which amounted to $20 million at a time when there may have been a material event pending (before they pushed back ADCOM). In my opinion, the SEC should be looking at this sale of stock. He had owned the stock 5-7 years so why did he sell unless he knew the or heard that the company would not be successful at the meeting and why did Steiner allow the sale at the time? This, in my opinion, is looking very suspicious to me and I was wondering what the thoughts of the other shareholders are?