---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-22-019022"
form_type: "8-K"
ticker: "GLSI"
cik: "0001799788"
company_name: "Greenwich LifeSciences, Inc."
filed_at: "2022-07-11T23:59:59+00:00"
generated_at: "2026-06-24T17:41:27.065147+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001493152-22-019022
- form_type: 8-K
- ticker: GLSI
- cik: 0001799788
- company_name: Greenwich LifeSciences, Inc.
- filed_at: 2022-07-11T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1799788/000149315222019022/0001493152-22-019022-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1799788/000149315222019022/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-22-019022
- JSON: https://secwatch.observer/filing/0001493152-22-019022.json
- Plain text: https://secwatch.observer/filing/0001493152-22-019022.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.