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FDA recognizes the substantial public interest in medicines that are being studied for the prevention or treatment of COVID-19, especially those medicines that may provide a benefit to patients with the most severe forms of disease that can result in respiratory failure and death. Leronlimab, a monoclonal antibody investigational drug under development by CytoDyn, Inc. (CytoDyn), is one of the potential medicines that has been studied to determine whether it is safe and effective in treating patients with COVID-19, including those with severe outcomes from COVID-19.
CytoDyn has conducted two separate clinical trials investigating leronlimab for the treatment of COVID-19. A smaller trial, titled CD10, which included 86 patients, studied leronlimab’s effect on mild-to-moderate COVID-19 disease. A larger trial, titled CD12, which included 394 patients, studied leronlimab’s effect on severe symptoms of respiratory illness associated with COVID-19. CytoDyn has communicated information to the public about the results of these trials. Although FDA generally cannot disclose confidential information about unapproved products, we have concluded that given the significant public interest in leronlimab, it is important to provide summary information about the status of the CytoDyn development program.
First, we underscore the significance of a well-designed clinical trial when evaluating whether a medicine is safe and effective for a particular use. Well-designed trials have specific objectives, referred to as “endpoints”, that are documented (i.e., pre-specified) in the study protocol before the initiation of the investigation. Data obtained from the clinical trial are later analyzed using pre-specified statistical methodologies. If the analyses of the primary and secondary endpoints do not support conclusions of the medicine’s benefit, then FDA considers subgroup analyses to be exploratory, meaning they may inform the design of future trials, but do not support reliable conclusions about the medicine’s benefit. Focusing on only the most favorable of many subgroup analyses, even if the sub-groups are pre-specified, can lead to overestimating the evidence of benefit, because regardless of a drug’s true efficacy, some analyses are likely to appear favorable by chance when a large number of analyses are conducted.
With the conclusion of both the CD10 and CD12 clinical trials, it has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19. In the smaller study that CytoDyn conducted in patients with mild-to-moderate COVID-19 disease (CD10), there was no observed effect of the drug on the study’s primary endpoint or on any of the secondary endpoints. The primary endpoint for the CD10 trial relied on a measure of participants’ COVID-19 symptoms called a “total clinical symptom score”, which was assigned based on the severity of each participant’s fever, muscle aches, shortness of breath, and cough. This score ranged from 0 (no symptoms) to 12 (all 4 symptoms present and severe). The CD10 trial results showed no clinically meaningful differences in average change in “total clinical symptom score” from baseline to Day 14 between study arms (-3.5 in the leronlimab group versus -3.4 in the placebo group). Additionally, none of the secondary endpoints were met in this study, including mortality, time to symptom resolution, and time to return to normal activity. Taken together, the CD10 results indicate that most study participants experienced resolution in COVID-19 symptoms regardless of whether they received leronlimab or placebo.
The larger trial that CytoDyn conducted in patients with severe COVID-19 disease (CD12) also failed to find any effect of the drug on the primary study endpoint, with no difference seen in mortality (20.5% in the leronlimab treatment group and 21.6% in the placebo treatment group); or on any of the secondary endpoints, for example, with no difference on the average length of hospitalization (21.4 days in both the leronlimab and the placebo treatment groups).
CytoDyn has publicly communicated differences in small subgroups from the CD12 trial (e.g., a sub-group analysis of 62 of the 394 patients studied) suggesting that the data demonstrated a mortality benefit in certain patients who had received leronlimab. Subgroup analyses have well-established limitations, especially in the context of a clinical trial that has failed to show a benefit in the overall study population. For example, subgroups are often small, and therefore imbalances are common. Here, the data from CD12 illustrated imbalances in mortality among subgroups, some favoring leronlimab and some favoring placebo. None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons. However, as noted above, such analyses may inform the design of future clinical trials investigating leronlimab for the treatment of COVID-19.
If CytoDyn plans further studies of leronlimab to determine whether the drug can provide clinical benefit to individuals with COVID-19, FDA will continue to provide advice to the company on their development program.
FDA recognizes the critical unmet medical need for new, effective treatments for COVID-19, especially for severe forms of the disease. We are committed to working with sponsors of novel therapies to facilitate development and approval of new treatments.
https://www.fda.gov/drugs/drug-safety-and-availability/statement-leronlimab?Mon,%2017%20May%202021%2014:59:28%20EDT CNBC REPORTING ON THE CALL TO OUST NADER!
https://www.cnbc.com/2021/07/24/large-shareholder-group-calls-for-a-board-overhaul-at-pharma-company-cytodyn.html CYTODYN UNDER FEDERAL INVESTIGATION!!! Securities and Exchange Commission and Department of Justice Investigations
The Company has received subpoenas from the United States Securities and Exchange Commission requesting documents and information concerning, among other matters, leronlimab, the Company’s public statements regarding the use of leronlimab as a potential treatment for COVID-19 and related communications with the FDA, investors, and others, and trading in the securities of CytoDyn. The SEC has informed the Company that this inquiry should not be construed as an indication that any violations of law have occurred or that the SEC has any negative opinion of any person, entity or securities trading activity.
In addition, the Company and certain of its executives have received subpoenas in connection with an investigation being conducted by the United States Department of Justice. The subpoenas seek testimony and/or records concerning, among other matters, leronlimab, the Company’s public statements regarding the use of leronlimab as a potential treatment for COVID-19 and related communications with the FDA, investors, and others, and trading in the securities of CytoDyn.
10/26/21 Cytodyn vs Amarex court filing exhibit:
From: Nader Pourhassan <npourhassan@cytodyn.com>
Sent: Tuesday, April 14, 2020 10:49 AM
To: Kush Dhody <kushd@amarexcro.com>; Kazem Kazempour <kazemk@amarexcro.com> Cc: Nitya Ray <nray@cytodyn.com>
Subject: BLA submission
Dear Nitya and Kush:
Today we have so far in 1 hour almost 20% drop in our stock price. Yesterday we had drop also after putting out great results about COVID-19 patients we are seeing these type of decline.
This drop will be much deeper if we don’t file our BLA as the message board now is getting bombarded by investors who are very frustrated with me and CytoDyn.
Please file the BLA no later than next week Wednesday, even if we are short in no matter what portion of whatever it is that we are short.
Dear Nitya: Please communicate with Kush about how much time they need to prepare the CMC portion after you send it to them. Kush told me yesterday he needs one week if so, they need the CMC package tomorrow to make the next week's Wednesday deadline. Please talk to Kush to see if there is any way they could take 1-2 days to prepare the CMC portion for final filling as you and I discussed yesterday
Dear Kush: The COVID-19 is no longer CytoDyn’s top priority as if the stock continues its drift then financially we will have problems financing itself. THE MOST IMPORTANT thing now is BLA. Please focus on that urgently only.
With best regards Nader
12/21/21 Amended Class Action Complaint
https://zlk-core-prod.s3.amazonaws.com/core/storage/app/cases/13564/events/12319/US_DIS_WAWD_3_21cv5190_83_AMENDED_COMPLAINT_for_Violations_of_the_Federal_Se_1640278818.pdf
EXPANDED FEDERAL INVESTIGATION
Securities and Exchange Commission and Department of Justice Investigations
The Company has received subpoenas from the United States Securities and Exchange Commission (“SEC”) and the United States Department of Justice (“DOJ”) requesting documents and information concerning, among other matters, leronlimab, the Company’s public statements regarding the use of leronlimab as a potential treatment for COVID-19, HIV, and triple-negative breast cancer, related communications with the FDA, investors, and others, litigation involving former employees, the Company’s retention of investor relations consultants, and trading in the Company’s securities. Certain Company executives have received subpoenas concerning similar issues and may be interviewed by the DOJ or SEC in the future. The SEC informed the Company that its inquiry should not be construed as an indication that any violations of law have occurred or that the SEC has any negative opinion of any person, entity or security.
The Company is cooperating fully with these non-public, fact-finding investigations, and as of the date of this filing, the Company is unable to predict the ultimate outcome and cannot reasonably estimate the potential possible loss or range of loss, if any.
CytoDyn board of directors removes CEO - The Columbian
CytoDyn Announces Partial Clinical Hold of HIV Program and Full Clinical Hold of COVID-19 Program
VANCOUVER, Washington, March 30, 2022 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on its HIV program and a full clinical hold on its COVID-19 program in the United States. Further, the Company elected to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting and is in the process of reevaluating the timing of its HIV BLA resubmission.
The Company was not enrolling any new patients in the trials placed on hold in the United States. The partial clinical hold on the HIV program impacts patients currently enrolled in extension trials. These patients will be transitioned to other available therapeutics and no clinical studies can be initiated or resumed until the partial clinical hold is resolved. CytoDyn intends to work closely with the FDA to resolve the partial clinical hold as soon as possible. Under the full clinical hold on the COVID-19 program, no new clinical studies may be initiated until the clinical hold is resolved. The Company is not currently conducting any COVID-19 trials in the United States, as it is evaluating the most optimal programs on which to focus its resources and attention.
“CytoDyn is committed to FDA compliance,” said Scott A. Kelly, M.D., Chief Medical Officer of CytoDyn. “We are evaluating our clinical programs and are working to resolve the issues underlying the clinical holds as soon as possible in close communication with the FDA. We will provide an update when we have additional information.”
https://stockhouse.com/news/press-releases/2022/03/30/cytodyn-announces-partial-clinical-hold-of-hiv-program-and-full-clinical-hold-of#:~:text=VANCOUVER%2C%20Washington%2C%20March%2030%2C%202022%20%28GLOBE%20NEWSWIRE%29%20--,on%20its%20COVID-19%20program%20in%20the%20United%20States.?msclkid=6f699d5cb06d11ecbfe40c1386e5e83d Related 2007 Voluntary Chapter 11 filing Petition
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