other material
confidence high
sentiment neutral
materiality 0.65
Greenwich LifeSciences expands Phase III Flamingo-01 arm to 250 patients; European sites pending
Greenwich LifeSciences, Inc.
- DSMB recommended continue as is; no serious adverse events related to GLSI-100 reported to date.
- Non-HLA-A*02 open-label arm expanded from 100 to 250 patients per Steering Committee guidance.
- European regulatory approval expected 2024; contracts for 105-120 sites in Spain, France, Germany, Italy, Poland.
- First 3 commercial lots of GP2 completed in 2023; enough for ~200,000 doses; commercial vial filling planned 2024.
- Phase II data review found potential recurrence in treated arm (Q4 2023); company states no material effect on study power.