Brief: AB Science Submits Response To EMA Masitinib Regulatory Review
04/04/2023 17:28
April 4 (Reuters) - AB Science SA ABS.PA :
* AB SCIENCE ANNOUNCES THAT IT HAS SUBMITTED ITS RESPONSE TO
DAY
120 QUESTIONS IN EMA REGULATORY REVIEW OF MASITINIB IN
AMYOTROPHIC LATERAL SCLEROSIS AND CLARIFIES NEW TIMELINE FOR
RESPONDING TO HEALTH CANADA
* AS PART OF ONGOING EMA PROCEDURE, AB SCIENCE HAS SUBMITTED
ITS
RESPONSES TO DAY 120 ASSESSMENT OF PROCEDURE
* AB SCIENCE, IN AGREEMENT WITH HEALTH CANADA, HAS EXTENDED
RESPONSE PERIOD TO HEALTH CANADA BY 30 DAYS
* NEW DEADLINE TO RESPOND TO HEALTH CANADA IS APRIL 12, 2023
Source text for Eikon: ID:nGNX1FQ8Bw
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