GCT has achieved a significant milestone by obtaining Regulatory Approval in India for a Phase III double-blind study focused on chronic idiopathic (immune) thrombocytopenic purpura, involving 90 patients. Currently, we are diligently moving forward with the next steps in the study start-up process. This includes the application for the Investigational Drug Import License, submissions to Local Ethics Committees, organizing an investigator meeting, and finalizing clinical trial agreements with various sites. Our goal is to facilitate the site activation process efficiently, enabling us to enroll the first patient by the end of this year.
With our office expansion in India last year, GCT stands ready to meet the growing demand for both global and local clinical drug development programs. We are committed to advancing medical research and contributing to the healthcare landscape in India and beyond.