Brief: Sesen Bio Says Participated In Type C Meeting With U.S. FDA

Carisma Therapeutics

30/03/2022 13:15

March 30 (Reuters) - Sesen Bio Inc  SESN.O :
    * SESEN BIO INC - ON MARCH 28, CO PARTICIPATED IN A TYPE C
MEETING
WITH U.S. FOOD AND DRUG ADMINISTRATION
    * SESEN BIO - FDA AGREED TO MAJORITY OF CO'S PROPOSED
PROTOCOL FOR
ADDITIONAL PHASE 3 CLINICAL TRIAL FOR POTENTIAL RESUBMISSION OF
BLA FOR VICINEUM
    * SESEN BIO-FDA AGREED TO MAJORITY OF STATISTICAL ANALYSIS
PLAN
DESIGN ELEMENTS FOR ADDITIONAL PHASE 3 TRIAL FOR POTENTIAL
RESUBMISSION OF VICINEUM BLA
    * SESEN BIO - CO PLANS TO FURTHER ENGAGE FDA IN COMING
MONTHS TO
ALIGN ON REMAINING OUTSTANDING ITEMS RELATED TO ADDITIONAL PHASE
3 CLINICAL TRIAL

Further company coverage:  SESN.O 

 ((Reuters.Briefs@thomsonreuters.com;))