Cytodyn Inc (CYDY)

[janice shell]

Did CYDY say the FDA denied lifting the full hold?

So it seems:

Clinical hold on HIV program

In March 2022, the FDA placed a partial clinical hold on the Company’s HIV program. The Company was not enrolling any new patients in the trials placed on hold in the United States. In October 2022, the Company voluntarily withdrew its BLA submission due to management’s conclusion that a significant risk existed that the BLA would not receive FDA approval due to the inadequate process and performance around the monitoring and oversight of the clinical data from its clinical trials by its former CRO.

During the third quarter ended February 28, 2023, the Company submitted the documents requested by the FDA in its March 2022 clinical hold letter. Subsequently, the FDA responded through written communication to the Company, requesting additional information and clarification regarding an item that was previously submitted, the benefit-risk assessment for the HIV population, and made a supplemental request that the Company submit an investigational new drug (“IND”) amendment containing the proposed general investigational plan for the coming year, appropriate protocols, and any additional information supporting the proposed investigation under the HIV program IND.

In March 2023, the Company responded to and submitted to the FDA the additional information and clarifications requested for the items previously requested. The FDA responded with further written communication requesting information relating to the benefit-risk assessment, as well as requesting the submission of a new protocol for the HIV indication.? At the end of March 2023, the Company and the FDA held an informal meeting in which the FDA addressed certain clarifying questions with respect to the clinical hold submission and further information requests made by the FDA.

In November 2023, the Company submitted a response to the FDA’s March 2022 clinical hold letter addressing comments received through previous incomplete response communications and during the informal meeting. The Company held a series of advisory board meetings with key opinion leaders (“KOLs”) in the HIV space to further inform responses to the FDA’s comments with regard to the benefit-risk analysis and an appropriate population of patients for a future clinical trial in HIV who could benefit from leronlimab given the current competitive landscape.

In early December 2023, the FDA notified the Company that the partial clinical hold on the HIV program had been lifted. At the same time, the FDA notified the Company that it had issued a new full clinical hold as it relates to the newly proposed clinical trial protocol submitted alongside the Company’s complete response to the partial clinical hold. The FDA’s new hold and comments relate to the design of the trial in particular with regard to the measurement of endpoints, controls arms, dose selection, and study-stopping rules. The newly proposed HIV clinical trial is a Phase II study evaluating the effects of 24 weeks of leronlimab on chronic immune activation and inflammation in cisgender men and women and transgender women living with HIV. Chronic immune activation and inflammation is a complicated and critical unmet need which causes strokes, heart attacks, and other vascular events and remains the leading cause of death in people with HIV. In late January 2024, the Company made its responsive submission to the FDA’s December 2023 comments and guidance in relation to its proposed clinical trial protocol. The Company anticipates moving forward with the contemplated clinical trial during the 2024 calendar year in the event that its efforts to obtain lifting of the clinical hold are successful.

https://www.sec.gov/Archives/edgar/data/1175680/000155837024001547/cydy-20240130x424b3.htm