Brief: Cytodyn Got Refusal To File Letter From FDA For BLA For Leronlimab As A Combination Therapy With Haart For Highly Treatment Experienced HIV Patients

Cytodyn

13/07/2020 14:19

July 13 (Reuters) - Cytodyn Inc  CYDY.PK :
    * UPDATE ON HIV-BLA-PDUFA: FDA REQUESTED MORE INFORMATION TO
COMPLETE A SUBSTANTIVE REVIEW. NO ADDITIONAL TRIALS REQUIRED.
CYTODYN PLANS TO SUBMIT THE REQUESTED INFORMATION AND WILL ASK
FOR A TYPE A MEETING WITH THE FDA PER THE AGENCY’S SUGGESTION
    * CYTODYN - GOT REFUSAL TO FILE LETTER FROM FDA FOR BLA FOR
LERONLIMAB AS A COMBINATION THERAPY WITH HAART FOR HIGHLY
TREATMENT EXPERIENCED HIV PATIENTS
    * CYTODYN INC - IS CONFIDENT IT CAN PROVIDE ALL INFORMATION
REQUESTED BY FDA
    * CYTODYN INC - INTENDS TO REQUEST A TYPE A MEETING WITH FDA
TO
DISCUSS ITS REQUEST FOR ADDITIONAL INFORMATION
    * CYTODYN - FDA'S REQUEST DOES NOT REQUIRE ANY ADDITIONAL
CLINICAL
TRIALS TO BE CONDUCTED, RATHER CO TO CONDUCT ADDITIONAL ANALYSIS
OF COMPLETED TRIALS

Source text for Eikon:  ID:nGNX5nt01w 
Further company coverage:  CYDY.PK 

 (Reuters.Briefs@thomsonreuters.com)