Clinical Trial SuccessThe trial demonstrated a median PFS of 19.4 months in combination therapy versus 11.0 months with pembrolizumab alone, showing an impressive 8+ month benefit in median PFS.
Regulatory ProgressThe management intends to file for approval by the end of the year and is seeking Priority Review, indicating a proactive strategy despite challenges.
Strategic Regulatory MovesCompany plans to meet with FDA on Ph3 trial design for Cylembio in advanced.