April 20, 2000 -- Gliatech Submits ADCON-P Module To FDA....

From: Helen Dynda (olddad66@runestone.net)
Tue Jun 20 13:10:26 2000

This article will give you some understanding about the process, which Gliatech and other companies ( such as Genzyme General and Lifecore Biomedical ) must complete before their product is ready to be presented to the Federal Drug Administration for its approval:

GLIATECH SUBMITS ADCON®-P PRECLINICAL MODULE TO FDA Cleveland, OH-April 20, 2000 -- Gliatech Inc. (Nasdaq: GLIA) today announced that it has submitted to the Food and Drug Administration (FDA) the second technical module for ADCON®-P under the Pre-market Approval (PMA) application "modular review" process. This module contains the results of biocompatibility and preclinical safety and effectiveness studies.

The modular review process permits companies to submit the necessary sections of the PMA in stages, allowing the FDA to begin its review process as the modules are submitted. The Company announced earlier the acceptance of PMA modular application and the first administrative module by the FDA. The Company must still submit the manufacturing and clinical data, and these submissions are expected to occur in the last half of 2000.

Gliatech's ADCON®-P is a proprietary, resorbable, carbohydrate polymer liquid designed to inhibit postsurgical scarring and adhesions following gynecological pelvic surgery. The Company is conducting a pivotal trial for ADCON®-P at approximately 20 sites and in more than 200 patients undergoing minimally invasive gynecological surgery. The Company expects to complete patient enrollment in its pivotal clinical trial for ADCON®-P in the second quarter of 2000.


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