SPY457.40+6.90 1.53%
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IXIC15,381.32+127.27 0.83%

BRIEF-Gamida Cell Provides Update On Pre-BLA Meeting With FDA For Omidubicel

reuters.com · 11/11/2021 07:01
BRIEF-Gamida Cell Provides Update On Pre-BLA Meeting With FDA For Omidubicel

- Gamida Cell Ltd GMDA:

  • GAMIDA CELL PROVIDES UPDATE ON PRE-BLA MEETING WITH FDA FOR OMIDUBICEL

  • GAMIDA CELL LTD - BLA SUBMISSION EXPECTED IN FIRST HALF OF 2022

  • GAMIDA CELL LTD - FDA REQUESTED REVISED ANALYSIS OF MANUFACTURING DATA GENERATED AT GAMIDA CELL'S COMMERCIAL MANUFACTURING FACILITY

  • GAMIDA CELL LTD - GAMIDA CELL CONDUCTED PRE-BLA MEETING FOR OMIDUBICEL WITH FDA

  • GAMIDA CELL LTD - FDA DID NOT REQUEST ADDITIONAL CLINICAL DATA TO INITIATE BLA SUBMISSION ONCE ANALYTICAL COMPARABILITY IS DEMONSTRATED

Source text for Eikon: ID:nBw8PBq52a

Further company coverage: GMDA


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