FDA approves first GP2 batch for breast cancer trial, 200,000 doses

Greenwich LifeSciences (Nasdaq: GLSI) said the FDA approved use of the first commercially manufactured lot of GP2 vials in the Phase III FLAMINGO-01 trial of GLSI-100 to prevent breast cancer recurrence. The company noted three commercial active-ingredient lots made in 2023 (enough for ~200,000 doses), one finished vial lot filled in 2024, and stability programs yielding 3 years of stability data supporting vial expiration. GLSI plans to start using the new vials at 40 US sites in the coming weeks and expects to submit commercial manufacturing data to support a US BLA filing under Fast Track.

https://www.stocktitan.net/news/GLSI/greenwich-life-sciences-announces-fda-approves-use-of-commercially-yu7037oeckzm.html