Monday, September 15, 2025
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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GLSI-100 Received Fast Track Designation. Greenwich LifeSciences announced that GLSI-100 has received Fast Track designation from the FDA. In the near term, this designation allows GLSI increased communications and more FDA meetings regarding regulatory requirements for its clinical trial data and use of biomarkers. Once the FLAMINGO-01 trial is completed, GLSI will be eligible to apply for Accelerated Approval and Priority Review, potentially shortening the time to market.
The Designation Mirrors The Trial Entry Criteria. GLSI-100 has received Fast Track Designation from the FDA for the treatment of “patients with HLA-A*02 genotype and HER2-positive breast cancer who have completed treatment with standard of care HER2/neu targeted therapy to improve invasive breast cancer free survival…” This includes the clinical trial entry criteria and endpoints for the current double-blind arms of the trial.
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