(CercleFinance.com) – Based on its updated timetable, AB Science indicates that it anticipates the CHMP’s decision regarding its application for marketing authorization for its masitinib in ALS (amyotrophic lateral sclerosis) during the first quarter of 2024 .
The biopharmaceutical company requested, for regulatory reasons, an extension of the suspension of proceedings, a request which was accepted during the session of the CHMP (Committee for Medicinal Products for Human Use) from September 11 to 14.
Based on the current stage of work in progress, AB Science is confident that the current manufacturing process for masitinib complies with the new European Medicines Agency directive.