Brief: Abeona Therapeutics Announces Positive Pre-BLA Meeting With FDA For Eb-101 And Plans For BLA Submission

Abeona Therapeutics

30/08/2023 12:59

Aug 30 (Reuters) - Abeona Therapeutics Inc  ABEO.O :
    * ABEONA THERAPEUTICS ANNOUNCES POSITIVE PRE-BLA MEETING
WITH FDA
FOR EB-101 AND PLANS FOR BLA SUBMISSION
    * ABEONA THERAPEUTICS INC - INTENTION TO PROCEED WITH
SUBMISSION
OF A BIOLOGICS LICENSE APPLICATION TO U.S. FOOD AND DRUG
ADMINISTRATION FOR EB-101
    * ABEONA THERAPEUTICS INC - REACHED ALIGNMENT WITH FDA THAT
EB-101
CLINICAL EFFICACY AND SAFETY DATA APPEAR ADEQUATE TO SUPPORT A
BLA SUBMISSION
    * ABEONA - FDA ASKED TO INCLUDE IN BLA SUBMISSION ADDITIONAL
BACKGROUND, DATA SUPPORTING SCIENTIFIC RATIONALE UNDERLYING
EB-101 POTENCY, IDENTITY ASSAYS
    * ABEONA THERAPEUTICS - AGENCY ASKED SUPPLEMENTAL DATA ON
CERTAIN
CHEMISTRY, MANUFACTURING, AND CONTROLS AND CLINICAL TOPICS BE
INCLUDED IN BLA PACKAGE

Source text for Eikon:  ID:nGNX25g96H 
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