regulatory
confidence high
sentiment positive
materiality 0.80
FDA removes clinical hold on Greenwich LifeSciences' Flamingo-01 Phase III trial
Greenwich LifeSciences, Inc.
- FDA formally removed the clinical hold on July 11, 2022, allowing the Flamingo-01 Phase III trial to proceed.
- Clinical hold was related to manufacturing and pharmacy process issues; company has addressed them with additional testing commitments.
- Company has begun site initiation visits and will provide future updates on trial progress.
- GLSI-100 is the drug candidate under development for breast cancer immunotherapy.