Brief: Biophytis Files With EMA For Authorization To Initiate SARA-31 Phase 3 Study In Sarcopenia
15/05/2023 07:17
May 15 (Reuters) - Biophytis SA ALBPS.PA :
* HAS FILED WITH THE EMA FOR AUTHORIZATION TO INITIATE
SARA-31
PHASE 3 STUDY IN SARCOPENIA
* LAUNCH OF PHASE 3 PROGRAM FOLLOWS ENCOURAGING RESULTS FROM
SARA-INT PHASE 2B STUDY AND INTERACTIONS WITH HEALTH AUTHORITIES
IN 2022
* EXPECTS A RESPONSE FROM REGULATORY AUTHORITIES IN NEXT
QUARTER,
WHICH WOULD ALLOW BIOPHYTIS TO INITIATE STUDY IN BELGIUM IN
FOLLOWING QUARTER
* IS CURRENTLY WORKING ON PREPARATION OF DOCUMENTS TO BE
SUBMITTED
TO FDA IN ORDER TO REQUEST APPROVALS TO INITIATE PHASE 3 STUDY
ALSO IN UNITED STATES
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