Brief: Gamida Cell Provides Regulatory Update On Omidubicel

Gamida Cell

21/11/2022 21:56

Nov 21 (Reuters) - Gamida Cell Ltd  GMDA.O :
    * GAMIDA CELL PROVIDES REGULATORY UPDATE ON OMIDUBICEL
    * GAMIDA CELL PROVIDES REGULATORY UPDATE ON OMIDUBICEL
    * GAMIDA CELL LTD - RECENT COMPANY SUBMISSION IN RESPONSE TO
FDA
REQUEST EXTENDS PDUFA DATE BY THREE MONTHS
    * GAMIDA CELL LTD-  FDA ALSO RESCHEDULED GAMIDA CELL'S
LATE-CYCLE
MEETING TO Q1 OF 2023
    * GAMIDA - FDA ISSUED INFORMATION REQUEST & VIEWED DATA IN
RESPONSE AS  MAJOR AMENDMENT, RESULTING IN EXTENSION OF
OMIDUBICEL PDUFA DATE TO MAY 1, 2023
    * GAMIDA CELL LTD - DATA FDA REQUESTED WERE LABORATORY
RESULTS FOR
INTERMEDIATE TIME POINTS FOR PATIENTS ENROLLED IN PHASE 3 STUDY

Source text for Eikon:  ID:nBw91tL4La 
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