AB Science is pleased to announce that Health Canada has deemed the request for reconsideration of masitinib in amyotrophic lateral sclerosis (ALS) to be admissible.

This reconsideration process will re-analyze, with new evaluators, the decision on the basis of the data in the initial dossier.

A Notice of Deficiency-Retraction (NOD-R) had been issued on February 19, 2024 by Health Canada concerning the submission dossier for masitinib in the treatment of ALS.

AB Science is working closely with the agency to facilitate the review of masitinib's conditional approval in ALS. AB Science has 45 days to file the request for reconsideration.
The central argument concerns the treatment of missing data.

The results of masitinib have been published over a period of 48 weeks and are positive when an appropriate methodology for handling missing data is applied. Masitinib therefore deserves careful consideration", commented Professor Albert Ludolph, Chairman of the Department of Neurology at Ulm University Hospital and Medical School.

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