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.
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.
An email has been sent to your address with instructions for changing your password.
There is no user registered with this email.
Sign Up
To create a free account, please fill out the form below.
Thank you for signing up!
A confirmation email has been sent to your email address. Please check your email and follow the instructions in the message to complete the registration process. If you do not receive the email, please check your spam folder or contact us for assistance.
Welcome to our platform!
Oops!
Something went wrong while trying to create your new account. Please try again and if the problem persist, Email Us to receive support.
