OrCel approval delayed
This article was originally published in The Gray Sheet
Executive Summary
Ortec International plans to meet with FDA to discuss the agency's request for a confirmatory trial demonstrating OrCel bi-layered cellular matrix' safety and effectiveness for treatment of venous ulcers. The meeting will determine whether the company initiates a resolution process with FDA or opts for an estimated 40-patient prospective clinical trial to gather more data to support the firm's PMA (1"The Gray Sheet" Feb. 7, 2005, p. 25). The trial, which likely would commence in July, would delay approval by roughly an additional nine months, Ortec estimates...