Greenwich LifeSciences Announces Removal of Clinical Hold Permitting Phase III Clinical Trial to Proceed

Rhea-AI Summary

Greenwich LifeSciences, Inc. (NASDAQ: GLSI) announced that the FDA has lifted the clinical hold on its Flamingo-01 Phase III clinical trial, allowing the company to proceed. The hold was previously imposed due to manufacturing and pharmacy process issues related to the candidate GP2. Following successful discussions and testing with the FDA, these concerns have been addressed. The trial is now moving forward with site initiation visits underway, and further updates on the trial's progress will be provided.

Positive

• FDA lifted clinical hold on Flamingo-01 Phase III trial.
• Company resolved manufacturing and pharmacy process issues.
• Site initiation visits for the trial have commenced.

Negative

• None.

STAFFORD, Texas--(BUSINESS WIRE)-- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, announced that the Food and Drug Administration (FDA) has removed the clinical hold permitting the Flamingo-01 Phase III clinical trial to proceed.

As previously announced, the Phase III clinical trial was placed on clinical hold by the FDA related to manufacturing and the pharmacy process. The Company through discussions with the FDA and testing of GP2 in the pharmacy process has satisfactorily addressed the clinical hold issues. The Company has committed to additional testing of GP2 in the pharmacy process. On July 11, 2022, the FDA formally removed the clinical hold and thus the Flamingo-01 Phase III clinical trial may proceed as planned. The Company has begun site initiation visits and will provide further updates on the progress of Flamingo-01 in the future.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220712005542/en/

Company Contact

Snehal Patel

Investor Relations

Office: (832) 819-3232

Email: info@greenwichlifesciences.com

Investor & Public Relations Contact for Greenwich LifeSciences

Dave Gentry

RedChip Companies Inc.

Office: 1-800-RED CHIP (733 2447)

Cell: (407) 491-4498

Email: dave@redchip.com

Source: Greenwich LifeSciences, Inc.

FAQ

What is the status of the Flamingo-01 Phase III clinical trial for GLSI?

The Flamingo-01 Phase III clinical trial for Greenwich LifeSciences has been approved to proceed after the FDA lifted the clinical hold.

What caused the clinical hold on the Flamingo-01 trial?

The clinical hold was due to issues related to manufacturing and the pharmacy process of the candidate GP2.

When was the clinical hold lifted by the FDA?

The FDA formally lifted the clinical hold on July 11, 2022.

What steps is GLSI taking following the lifting of the clinical hold?

Greenwich LifeSciences is conducting site initiation visits and will provide further updates on the trial's progress.

How does the FDA decision impact Greenwich LifeSciences' stock?

The FDA's decision to lift the clinical hold is likely seen as a positive development for investors, allowing the company to move forward with its clinical trial.