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Re: Since 2012 post# 230246

Thursday, 02/29/2024 10:00:18 AM

Thursday, February 29, 2024 10:00:18 AM

Post# of 232883
Read this--- "full hold" specifically mentioned in these filings:

The FDA notified the Company at the beginning of December 2023 that: (i) the FDA’s “partial hold” imposed in March 2022 had been lifted; and (ii) a new “full hold” had been applied related to the clinical trial protocol the Company submitted in November 2023 alongside the Company’s complete response to the partial clinical hold. The Company submitted a revised protocol to the FDA in January 2024, and will remain on clinical hold until the FDA clears the protocol.
https://www.sec.gov/Archives/edgar/data/1175680/000155837024001547/cydy-20240130x424b3.htm



The Company received a letter from the FDA at the beginning of December 2023 notifying the Company that: (i) the “partial hold” implemented by the FDA in March 2022 had been lifted; and (ii) a new “full hold” had been applied as it relates to the newly proposed clinical trial protocol submitted in November 2023 alongside the Company’s complete response to the partial clinical hold.

As a whole, the Company views this as a significant step in the right direction, as the partial clinical hold that had been in place since March 2022 has been resolved. That being said, the Company now needs to resolve the FDA’s comments associated with its newly proposed clinical trial protocol which resulted in the procedural “full hold” that is currently in place. The Company believes the “full hold” will be removed after we adequately respond to the FDA’s comments and incorporate the FDA’s specific guidance as it relates to the proposed protocol.
https://www.sec.gov/Archives/edgar/data/1175680/000155837023019804/cydy-20231214x8k.htm



Todays PR--- "clinical hold"

Wheres the 8K for todays news?

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