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Re: Bill_ENG post# 204292

Tuesday, 02/22/2022 11:58:52 AM

Tuesday, February 22, 2022 11:58:52 AM

Post# of 233119
I'll take ceasing distribution of leronlimab for $200 Alex---

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
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