This order is A Pre-TACT meeting for study and milestone discussion for a BPN Biologics project. POP: 03/09/2023 to 03/08/2024

Northwestern University At Chicago, Evanston IL

Investigators

Abstract

A cooperative agreement awarded under the BPN-Biologics program requires a pre-regulatory meeting to discuss studies and milestones and contribute to moving the promising therapeutic to IND-enabling work. The TREAT-NMD Advisory Committee for Therapeutics (TACT) meeting is an official step in moving therapeutics that address neuromuscular disorders towards IND applications. This pre-TACT meeting is an important preparatory step to prepare for TACT review. Northwestern University will support gathering 3 experts in neuromuscular disorders and TACT meetings to hold the pre-TACT meeting with the NINDS-supported investigator and other members of the NIH Lead Development Team supporting the investigator.