Posted by Michael Wonder on 27 Apr 2020
CytoDyn submits completed biologics license application to the FDA for leronlimab as a combination therapy for highly treatment experienced HIV patients
27 April 2020 - During the FDA’s review period, the Company will dedicate all resources to ensure availability of leronlimab for COVID-19 patients; cancer programs continue with positive results.
CytoDyn today announced the Company has submitted the clinical, and the CMC (chemistry, manufacturing and controls) portions of its application to the U.S. FDA for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients.
The FDA previously granted both fast track designation for leronlimab and rolling review for the Company’s application in HIV indication.
