---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-22-019038"
form_type: "8-K"
ticker: "GLSI"
cik: "0001799788"
company_name: "Greenwich LifeSciences, Inc."
filed_at: "2022-07-12T23:59:59+00:00"
generated_at: "2026-06-24T16:54:06.519699+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA removes clinical hold on Greenwich LifeSciences' Flamingo-01 Phase III trial

## Summary
- FDA formally removed the clinical hold on July 11, 2022, allowing the Flamingo-01 Phase III trial to proceed.
- Clinical hold was related to manufacturing and pharmacy process issues; company has addressed them with additional testing commitments.
- Company has begun site initiation visits and will provide future updates on trial progress.
- GLSI-100 is the drug candidate under development for breast cancer immunotherapy.

## SEC filing metadata
- accession: 0001493152-22-019038
- form_type: 8-K
- ticker: GLSI
- cik: 0001799788
- company_name: Greenwich LifeSciences, Inc.
- filed_at: 2022-07-12T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1799788/000149315222019038/0001493152-22-019038-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1799788/000149315222019038/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-22-019038
- JSON: https://secwatch.observer/filing/0001493152-22-019038.json
- Plain text: https://secwatch.observer/filing/0001493152-22-019038.txt

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