FDA clinical hold on GLSI-100 Phase III Flamingo-01 remains; manufacturing data submitted, review ongoing

Greenwich LifeSciences, Inc.

FDA placed clinical hold on Flamingo-01 trial for GLSI-100 (GP2) in HER2/neu positive patients, citing manufacturing issues.
Company completed manufacturing of three clinical lots of GP2 that meet release specifications; third lot made on commercial automated filling line.
FDA is reviewing manufacturing data and sent follow-up questions; company has responded.
Site initiation visits being scheduled to train clinicians and activate clinical sites.
No assurance when or if clinical hold will be released; risk factor supplemented.

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