AB Science receives Notice of Deficiency (NOD) from Health Canada for masitinib in the treatment of amyotrophic lateral sclerosis (ALS)
PRESS RELEASE
AB SCIENCE RECEIVES NOTICE OF DEFICIENCY (NOD) FROM HEALTH CANADA FOR MASITINIB IN THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)
AB SCIENCE HAS 90 CALENDAR DAYS TO RESPOND TO THE NOD
Paris, December 13, 2022, 6pm CET
AB Science SA (Euronext - FR0010557264 - AB) today announced that it has received a Notice of Deficiency (“NOD”) for its masitinib New Drug Submission in the treatment of amyotrophic lateral sclerosis.
This NOD means that Health Canada has requested the provision of additional information related to masitinib New Drug Submission. Until this information is provided to Health Canada, the review process has been halted.
If the scientific review of a submission has been completed and is found to be incomplete or non-compliant, a Notice of Non-compliance (NON) will be sent to the sponsor. The difference between a NOD and a NON is that the review of the submission is not complete when a NOD is issued. The Response to a Notice of Deficiency is to be submitted within 90 calendar days from the date the NOD was sent.
AB Science will liaise with Health Canada to address the deficiencies, with the intention to resume the process within the allocated timeframe.
About AB Science
Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment.
AB Science has developed a proprietary portfolio of molecules and the Company’s lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).
Further information is available on AB Science’s website:
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These forward-looking statements can often be identified by the words "expect", "anticipate", "believe", "intend", "estimate" or "plan" as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations.
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