SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 30, 2022
(Exact name of registrant as specified in its charter)
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|Item 8.01|| |
CytoDyn Inc. (the “Company”) reported today that the U.S. Food and Drug Administration (the “FDA”) recently placed a full clinical hold on its COVID-19 program and a partial clinical hold on its HIV program in the United States. The Company had previously paused its COVID-19 trials in Brazil.
Under the partial clinical hold on the Company’s HIV program, no clinical studies may be initiated or resumed until the partial clinical hold has been resolved. As a result of the partial clinical hold on the HIV program, patients currently enrolled in the extension trials will be transitioned to other available therapeutics. Under the full clinical hold on the COVID-19 program, no new clinical studies may be initiated until the clinical hold is resolved.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|Date: March 30, 2022||By|
Chief Financial Officer and Interim President