Greenwich LifeSciences' GLSI-100 Receives FDA Fast Track Designation for Breast Cancer Treatment

Greenwich LifeSciences' GLSI-100 has been granted Fast Track designation by the FDA for HLA-A*02 patient population with HER2-positive breast cancer. This may lead to earlier drug approval and expedite the Biologic License Application (BLA) filing process. The designation recognizes the potential of GLSI-100 to prevent metastatic breast cancer recurrence and fill unmet medical needs. The FDA review process encourages frequent communication between the FDA and the Company to ensure timely resolution of questions and issues.