Shuttle Pharmaceuticals announces results of pre-IND meeting with FDA

Shuttle Pharmaceuticals announced receipt of written responses to questions submitted for a Type B pre-Investigational New Drug Application meeting with the U.S. FDA. The FDA’s positive feedback and guidance on the company’s Chemistry, Manufacturing, and Controls and clinical protocol design for Ropidoxuridine provides a pathway to IND application submission in the fourth quarter of 2023 to initiate the Phase 2 clinical trial. The company remains on track to initiate the clinical trial in Q4 of 2023.