BRIEF-Replimune Group Disagrees With FDA About Whether Rp1 BLA Data Set Is Enough To Allow The Medicine To Be Made Available To Advanced Cancer Patients

Reuters04-11 05:11

April 10 (Reuters) - Replimune Group Inc REPL.O:

REPLIMUNE GROUP: DISAGREES WITH FDA ABOUT WHETHER RP1 BLA DATA SET IS ENOUGH TO ALLOW THE MEDICINE TO BE MADE AVAILABLE TO ADVANCED CANCER PATIENTS
REPLIMUNE GROUP: WE HAVE NO CHOICE BUT TO ELIMINATE JOBS, INCLUDING SUBSTANTIALLY SCALING BACK OUR U.S. BASED MANUFACTURING OPERATIONS
REPLIMUNE: BASED ON FDA FEEDBACK, STARTED IGNYTE-3 TO SATISFY REGULATORY REQUIREMENT THAT CONFIRMATORY STUDY BE UNDERWAY FOR ACCELERATED APPROVAL

Source text: ID:nGNX7W8lny

Further company coverage: REPL.O

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

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