Brief: Acticor Biotech Gives Update On U.S. Regulatory Discussion With FDA

Acticor Biotech SA

23/12/2022 07:11

Dec 23 (Reuters) - Acticor Biotech SA  ALACT.PA :
    * ACTICOR BIOTECH PROVIDES AN UPDATE ON US REGULATORY
DISCUSSION
WITH FDA
    * FDA ACKNOWLEDGED CONDUCT OF ONGOING PHASE 2/3 ACTISAVE,
ENCOURAGING ACTICOR BIOTECH TO SUBMIT NEW REQUEST FOR FAST TRACK
WITH ADDITIONAL SUPPORTIVE DATA FROM ACTISAVE STUDY
    * GROUP IS DISCUSSING WITH FDA TO SET UP A TYPE C MEETING
FOR
EARLY 2023 WITH SAME OBJECTIVE AS FOR RECENT MEETING WITH
EUROPEAN AGENCY EMA
    * ACTICOR BIOTECH INTENDS TO PURSUE DISCUSSION WITH FDA ON
ITS
CLINICAL DEVELOPMENT PROGRAM
    * OBJECTIVE WILL BE TO VALIDATE DESIGN AND STATISTICAL
ANALYSIS OF
INTERNATIONAL PHASE 2/3 STUDY, ACTISAVE TO SUPPORT POTENTIAL
FUTURE MARKETING AUTHORIZATION APPLICATION IN U.S.
    * ADDITIONAL CLINICAL EVIDENCE IS REQUESTED BY AGENCY TO
ACCEPT A
FAST TRACK DESIGNATION FOR GLENZOCIMAB

Source text for Eikon:  ID:nBwbkfyXCa 
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