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Re: bucweet34 post# 204560

Friday, 02/25/2022 11:37:36 AM

Friday, February 25, 2022 11:37:36 AM

Post# of 236637
No leronsaline available- FDA said vials are improperly labeled and cannot be introduced or transported for interstate commerce.

For the reasons discussed above, the video misbrands leronlimab under section 502(f)(1) of the FD&C Act and in violation of section 301(a) of the FD&C Act.

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.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cytodyn-inc-626957-02112022
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