Biomind Labs Inc. announced a Pre-Investigational New Drug (Pre-IND) meeting granted by the U.S. Food and Drug Administration (the FDA) for the Company's new chemical entity (NCE) Triptax. The Company has submitted a briefing package to the Division of Psychiatry, Center for Drug Evaluation and Research at the FDA, and awaits further feedback on the NCE Triptax. The Pre-IND meeting is a critical step in the U.S. regulatory approval process that provides an opportunity for the Company and the FDA to discuss the NCE development plan and to obtain the FDA's guidance for new clinical trials the Company may conduct on the NCE Triptax.
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- Biomind Labs Announces Pre-Ind Meeting Request Granted by FDA for Its New Chemical Entity Triptax Targeting Treatment-Resistant Depression