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Tuesday, February 22, 2022 11:58:52 AM
This letter notifies you of our concerns and provides you with an opportunity to address them. OPDP requests that CytoDyn cease any violations of the FD&C Act. Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this letter, listing all other promotional communications for leronlimab that contain representations such as those described above, and explaining any plan for discontinuing use of such communications, or for ceasing distribution of leronlimab.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cytodyn-inc-626957-02112022
Recent CYDY News
- Form 8-K - Current report • Edgar (US Regulatory) • 06/03/2024 09:15:10 PM
- Form SC TO-I - Tender offer statement by Issuer • Edgar (US Regulatory) • 06/03/2024 09:10:56 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 09:17:30 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 09:16:24 PM
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- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/01/2024 10:16:47 PM
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- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 02/22/2024 10:16:11 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 01/29/2024 01:40:14 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2024 02:04:57 AM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2024 02:02:59 AM
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