(CercleFinance.com) – AB Science announces that Health Canada has deemed the request for review of masitinib in amyotrophic lateral sclerosis (ALS) admissible.
This re-examination process will re-analyze, with new evaluators, the decision based on the data from the initial file.
A Notice of Deficiency-Withdrawal (AI-R) was issued on February 19, 2024 by Health Canada regarding the submission of masitinib in the treatment of ALS.
AB Science is working closely with the agency to facilitate the review of conditional approval of masitinib 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 48-week period and are positive when appropriate methodology to address missing data is applied. Masitinib therefore deserves careful consideration,’ commented Professor Albert Ludolph, Chairman of the Department of Neurology at the University Hospital and Faculty of Medicine Ulm.
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