secwatch.observer — SEC 8-K summary
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Issuer:     Greenwich LifeSciences, Inc. (GLSI)
CIK:        0001799788
Form:       8-K
Filed at:   2024-02-14T23:59:59+00:00
Accession:  0001493152-24-006664
Event type: other_material
Sentiment:  neutral
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Greenwich LifeSciences expands Phase III Flamingo-01 arm to 250 patients; European sites pending
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1799788/000149315224006664/0001493152-24-006664-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1799788/000149315224006664/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-006664

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer