Posted by Michael Wonder on 13 Jul 2020
FDA advises CytoDyn its application is incomplete
13 July 2020 - CytoDyn announced today it has received a refusal to file letter from the U.S. FDA regarding its biologics license application for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients.
CytoDyn is confident it can provide all information requested by the FDA.
CytoDyn previously announced it submitted all remaining parts of its application for leronlimab on May 11, 2020. Pursuant to FDA guidelines, CytoDyn informed the FDA it had submitted a complete application for rolling review. In its comments on May 13, CytoDyn stated as a next step after receiving the application, the FDA would start reviewing the application for completeness and would make a filing decision. The FDA has informed the Company its application does not contain certain information needed to complete a substantive review and therefore, the FDA will not file the application at this time.
