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NurExone Announces Plan to Submit Pre-Investigational New Drug Meeting Request to U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA) informed NurExone that it is at the appropriate s...
About this update from Nurexone Biologic Inc
[{"type":"text","content":"NurExone Announces Plan to Submit Pre-Investigational New Drug Meeting Request to U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration (FDA) informed NurExone that it is at the appropriate stage of its product development for a pre-Investigational New Drug (pre-IND) meetingA pre-IND meeting could potentially shorten the regulatory timeline for the launch of NurExone's ExoTherapy into the U.S. market.Calgary, Alberta--(Newsfile Corp. - November 2, 2022) - NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (the \"Company\" or \"NurExone\"), a biopharmaceutical company developing biologically-guided exosome therapy (\"ExoTherapy\") for patients with traumatic spinal cord injuries, is pleased to announce the Company's plan to submit a pre-IND meeting request to the FDA. Prior to submission of a New Investigational Drug (IND) application, in September 2022, the Company submitted a request for an Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) meeting, which is an informal, non-binding meeting that is offered by the U.S. FDA to companies at an early stage in product development. In an official response to the Company's INTERACT meeting request, the FDA informed NurExone that the Company is beyond the stage of participating in this informal meeting and is instead appropriate for the next type of formal meeting, known as a Pre-IND meeting in connection with the development of ExoPTEN, NurExone's first ExoTherapy product. A Pre-IND meeting provides applicants with information towards preparation of complete IND applications, reducing the risk of a clinical hold and outlining main guidelines for the applicant to plan and prepare its clinical studies for its product. As a result, a pre-IND meeting could potentially reduce the length of time needed by the Company to gain regulatory approval for launching its product in the U.S. market. Dr. Lior Shaltiel, CEO of NurExone, added, \"Proceeding directly to a Pre-IND meeting could save us several months and expedite the process of obtaining FDA approval for our ExoTherapy product. I believe that an accelerated regulatory timeline will allow us, subject to product approval, to gain a first-mover advantage in launching our unique exosome-based drug platform for treating traumatic spinal cord injuries in the United States.\" About NurExone Biologic Inc.Nur...