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Saturday, March 02, 2024 12:28:08 PM
Both the PR and yesterdays 424B3 filing failed to specifically mention the words "the newly proposed clinical trial protocol submitted in November 2023".
The November 2023 protocol was a no can do with the FDA---
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
Looking like the v.January 2024 didnt take either, somewhere a "softened up" version limped across the finish line.
Good call.
Recent CYDY News
- 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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