(Boursier.com) — AB Science indicates that the Committee for Medicinal Products for Human Use (CHMP) suggested that it respond in writing to the questions remaining unanswered at D195 of the procedure, instead of addressing these questions during the “Oral Explanation”, as part of the its application for marketing authorization for Masitinib in amyotrophic lateral sclerosis.
At stage D195 of the procedure, certain major objections remained and an Oral Explanation was scheduled for January 24 to respond to these objections.
AB Science has accepted this proposal, which is unusual at this stage of the procedure, as it offers AB Science the opportunity to give more detailed answers than during the Oral Explanation and gives the CHMP more time to evaluate the answers. A new Oral Explanation is not mandatory and will only be scheduled if major objections remain after review of the written responses.
AB Science now expects an opinion from the CHMP during the second quarter of 2024.
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