Enveric Biosciences receives FDA response, streamlines path for EB-003

Enveric Biosciences (ENVB) announced that it has received a written response from the FDA to its request for a pre-investigational new drug Type B meeting for its lead program, EB-003. In its response, the FDA indicated that the questions for the pre-IND meeting proposed by Enveric were a matter for IND application review and FDA recommends that Enveric proceed to submitting its IND application and protocol for review. Enveric interprets this outcome as consistent with the view that the company is sufficiently advanced in its development strategy to proceed past the pre-IND meeting milestone. As a result, Enveric will streamline its regulatory path by advancing toward the submission of its IND application for EB-003. The company views this transition as in alignment with its development strategy providing a clear path forward to clinical evaluation.