FDA WARNING_LETTER - CytoDyn, Inc. - February 11, 2022

The FDA issued a Warning Letter to CytoDyn, Inc. regarding a video interview featuring Dr. Nader Pourhassan, then CEO, discussing the investigational new drug leronlimab. The video, hyperlinked on CytoDyn's website, promoted leronlimab as safe and effective for COVID-19 treatment, despite it being an unapproved investigational drug without established safety or efficacy.

This constitutes misbranding under section 502(f)(1) and a violation of section 301(a) of the FD&C Act, as it promotes an investigational drug in a promotional context, which is prohibited by 21 CFR 312.7(a). The FDA highlighted that leronlimab's clinical trials (CD10 and CD12) did not support a clinical benefit for COVID-19, with the larger CD12 trial showing no effect on the primary endpoint of Day 28 all-cause mortality.

The FDA expressed public health concerns due to the misleading claims about leronlimab's efficacy for a severe disease like COVID-19, especially given the ongoing public health emergency. CytoDyn is required to cease all violations, submit a written response within 15 working days detailing corrective actions, list other similar promotional communications, and provide a comprehensive plan for truthful, non-misleading corrective communications to the affected audience. Failure to comply may result in further regulatory