(CercleFinance.com) – AB Science announces that the Canadian health authority (Health Canada) has issued a favorable opinion following the preliminary review of the registration dossier for masitinib in the treatment of amyotrophic lateral sclerosis ( ALS).
The file submitted by AB Science was thus deemed acceptable for a review which can therefore start. Under NOC/c (Notice of Compliance with Conditions) status, Health Canada has a maximum of 200 calendar days to review the file.
This authorization was made on the basis of a pre-submission dossier including efficacy data from the AB10015 study, long-term survival data (average follow-up of 75 months since diagnosis) and safety data. .
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