Brief: Acticor Biotech Announces Progress In Discussions With EU And U.S Regulatory Agencies

Acticor Biotech SA

30/05/2023 18:05

May 30 (Reuters) - Acticor Biotech SA  ALACT.PA :
    * ACTICOR BIOTECH: PROGRESS IN DISCUSSIONS WITH EU AND US
REGULATORY AGENCIES
    * THE FDA HAS PROVIDED VALUABLE FEEDBACK TO REINFORCE THE
PROPOSED
CLINICAL DEVELOPMENT  PLAN OF GLENZOCIMAB IN ACUTE ISCHEMIC
STROKE (AIS)
    * A NEW TYPE C CONSULTATION WITH THE FDA HAS BEEN GRANTED ON
THE
PHARMACEUTICAL  DEVELOPMENT PLAN
    * IN EUROPE ADDITIONAL SCIENTIFIC ADVICE REQUESTS UNDER THE
PRIME
PROGRAM HAVE BEEN  VALIDATED BY THE EMA
    * IN ACTISAVE STUDY, 300 PATIENTS HAVE ALREADY BEEN
RECRUITED AND
100 PATIENTS HAVE BEEN TREATED WITH THROMBOLYSIS AND
THROMBECTOMY, REACHING THE TARGET FOR THE FIRST FUTILITY
ANALYSIS
    * IN PARALLEL, A NEW FDA TYPE C CONSULTATION WAS GRANTED ON
THE
PHARMACEUTICAL DEVELOPMENT WITH  WRITTEN ANSWERS EXPECTED BY END
OF JULY 2023.

Source text for Eikon:  ID:nBw5tnB0ca 
Further company coverage:  ALACT.PA 

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