Brief: AB Science Announces Update In Marketing Authorization Application Of Masitinib

AB Science SA

26/01/2024 17:06

Jan 26 (Reuters) - AB Science SA  ABS.PA :
    * ANNOUNCES UPDATE IN MARKETING AUTHORIZATION APPLICATION OF
MASITINIB IN AMYOTROPHIC LATERAL SCLEROSIS AT THE EUROPEAN
MEDICINES AGENCY
    * A DECISION FROM THE EUROPEAN MEDICINES AGENCY IS EXPECTED
DURING
THE SECOND QUARTER OF2024
    * AT  D195  OF  THE  PROCEDURE,  CERTAIN  MAJOR  OBJECTIONS 
REMAINED,  AND  AN  ORAL  EXPLANATION  WAS  SCHEDULED  ON
JANUARY 24, 2024 TO ADDRESS THESE OBJECTIONS.
    * THIS WEEK, BEFORE DATE PLANNED DATE OF ORAL EXPLANATION,
CHMP
HAS PROPOSED THAT AB SCIENCE ADDRESSES THESE OBJECTIONS IN
WRITING INSTEAD OF THE ORAL EXPLANATION
    * AB SCIENCE HAS ACCEPTED THIS PROPOSAL, WHICH IS UNUSUAL AT
THIS
STAGE OF THE PROCEDURE, AS IT OFFERS AB SCIENCE THE POSSIBILITY
OF GIVING MORE DETAILED RESPONSES THAN WHAT WOULD BE  POSSIBLE
DURING AN ORAL EXPLANATION, AND PROVIDES CHMP WITH MORE TIME TO
EVALUATE THE RESPONSES
    * A NEW ORAL EXPLANATION IS NOT MANDATORY AND WILL BE
SCHEDULED
ONLY IF MAJOR OBJECTIONS REMAIN AFTER THE REVIEW OF THE WRITTEN
RESPONSES

Further company coverage:  ABS.PA 

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