Brief: Athersys Announces Successful Type B Meeting With The FDA

Athersys

22/03/2023 12:33

March 22 (Reuters) - Athersys Inc  ATHX.O :
    * ATHERSYS ANNOUNCES SUCCESSFUL TYPE B MEETING WITH THE FDA
    * ATHERSYS INC - ATHERSYS WILL CHANGE TIMING OF PRIMARY
ENDPOINT
ASSESSED BY SHIFT ANALYSIS IN MODIFIED RANKIN SCALE (MRS) SCORE
TO DAY 365
    * ATHERSYS INC - WILL RETAIN SHIFT ANALYSIS IN MRS SCORE AT
DAY 90
AS A KEY SECONDARY ENDPOINT, ALONG WITH OTHER REVISED SECONDARY
ENDPOINTS
    * ATHERSYS INC - WILL REMOVE ELIGIBILITY CAPS ON CONCOMITANT
REPERFUSION THERAPY TO ENSURE STUDY POPULATION IS REFLECTIVE OF
CURRENT STANDARD OF CARE
    * ATHERSYS INC - MAY ELECT TO HAVE AN INDEPENDENT
STATISTICIAN
CONDUCT AN INTERIM ANALYSIS TO ASSESS POTENTIAL SAMPLE SIZE
ADJUSTMENT
    * ATHERSYS INC - MASTERS-2 CURRENTLY PLANS TO ENROLL 300
PATIENTS
AND ENROLLMENT, AS PREVIOUSLY COMMUNICATED, IS >50% COMPLETE

Source text for Eikon:  ID:nBw6QNLxra 
Further company coverage:  ATHX.O 

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