Brief: Gensight Says 3 Validation Batches Produced For LUMEVOQ's MAA

Gensight Biologics SA

04/11/2021 06:34

Nov 4 (Reuters) - GENSIGHT BIOLOGICS SA  SIGHT.PA :
    * GENSIGHT BIOLOGICS PROVIDES UPDATE ON MANUFACTURING
TIMELINE
NEEDED FOR LUMEVOQ REGULATORY FILING
    * THREE VALIDATION BATCHES HAVE BEEN PRODUCED AS REQUIRED
FOR
LUMEVOQ®'S MARKETING AUTHORISATION APPLICATION IN EUROPE
    * BATCHES HAVE PERFORMED AS EXPECTED, WITH CONSISTENCY
BETWEEN
RUNS
    * TECHNICAL ISSUE IN A FINAL STEP OF DOWNSTREAM PROCESS WILL
REQUIRE COMPANY TO REPEAT THESE VALIDATION BATCHES
    * ROOT CAUSE INVESTIGATIONS HAVE ASSESSED TECHNICAL ISSUE AS
RELATED TO OPERATIONAL CONDITIONS AND NOT AT ALL TO INTRINSIC
DESIGN OF MANUFACTURING PROCESS

Source text for Eikon:  ID:nBwFckBKa 
Further company coverage:  SIGHT.PA 

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