09:57 AM EST - NeonMind Biosciences Inc. : Announced today it successfully completed a pre-Investigational New Drug (IND) consultation with the U.S. Food and Drug Administration (FDA), regarding proposed clinical trials for NeonMind's lead obesity drug candidate, NEO-001. The Company expects to initiate a Phase 1/2 clinical study in the first half of 2022. "We are extremely pleased with the FDA's feedback and the outcome of the pre-IND consultation, which validated the scientific hypothesis and clinical approach developed by the NeonMind team. The FDA provided helpful feedback and constructive recommendations for the next steps in our development plan. We appreciate the FDA's guidance and are on track to bring the first and only psychedelic-based treatment for obesity into clinical trials," said Robert Tessarolo, President & CEO of NeonMind. "In parallel with an IND submission, we plan to engage with a Contract Research Organization and qualify clinical sites to move expeditiously into a Phase 1/2 Proof-of-Concept study." NeonMind Biosciences Inc.
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