Posted by Michael Wonder on 10 May 2020
CytoDyn clarifies status of biologics license application
8 May 2020 - CytoDyn today further clarified the status of the Company’s submission of its biologics license application to the U.S. FDA for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients, filed on 27 April 2020 with the FDA.
The application will not be considered completed until the Company submits to the FDA clinical datasets required to address FDA comments it received in March 2020, as described in the Company’s press releases on May 4 and May 6, 2020.
CytoDyn expects to submit these clinical datasets on 11 May 2020.
