Brief: Diamedica Therapeutics Announced That FDA Has Placed A Clinical Hold On Company's Phase 2/3 Remedy2 Trial

DiaMedica Therapeutics

06/07/2022 21:48

July 6 (Reuters) - DiaMedica Therapeutics Inc  DMAC.O :
    * DIAMEDICA THERAPEUTICS INC - ANNOUNCED THAT U.S. FOOD AND
DRUG
ADMINISTRATION HAS PLACED A CLINICAL HOLD ON COMPANY'S PHASE 2/3
REMEDY2 TRIAL
    * DIAMEDICA THERAPEUTICS - CLINICAL HOLD INITIATED FOLLOWING
CO’S
PAUSE IN PATIENT ENROLLMENT, SUBMISSION OF THREE SERIOUS ADVERSE
EVENT REPORTS TO FDA
    * DIAMEDICA THERAPEUTICS -   PLANS TO SUBMIT REVISED REMEDY2
TRIAL
PROTOCOL WITH SUPPORTING RATIONALE AND DATA TO FDA FOR REVIEW IN
THE COMING WEEKS
    * DIAMEDICA THERAPEUTICS -  MAY NOT ENROLL ANY ADDITIONAL
PATIENTS
IN REMEDY2 TRIAL UNTIL CO PROVIDES FDA WITH ANALYSIS OF EVENTS
LEADING TO HYPOTENSION


Further company coverage:  DMAC.O 

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