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

Source: https://www.globalkeysolutions.net/records/warning_letter/cytodyn-inc/57ae6b8a-323e-4c3b-b6da-5d8723e74290

> FDA WARNING_LETTER for CytoDyn, Inc. on February 11, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: CytoDyn, Inc.
- Inspection Date: 2022-02-11
- Product Type: Drugs
- Office Name: Office of Prescription Drug Promotion
- Summary: 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

## Related Officers

- [Kathleen Klemm](https://www.globalkeysolutions.net/people/kathleen-klemm/8138437b-f7e9-4593-bbef-a99137a0832e)
- [Andrew S.T. Haffer](https://www.globalkeysolutions.net/people/andrew-st-haffer/bd5a9d2c-a0b2-40a2-a730-5f2f0e3f44f7)

Company: https://www.globalkeysolutions.net/companies/cytodyn-inc/e58c405e-80bb-47c7-9e48-8035b4107d1a

Office: https://www.globalkeysolutions.net/offices/office-of-prescription-drug-promotion/ef9d7ac0-99c5-4b8d-9153-cff47ba23edc