Gliatech Adcon
This article was originally published in The Gray Sheet
Executive Summary
Potential buyers of the firm's flagship anti-adhesion technology will have the option of finishing a 16-site pivotal trial to support gynecological and pelvic indications. The technology, including solution and gel formulation, is being auctioned as part of Gliatech's ongoing chapter 11 bankruptcy proceedings the firm filed in May (1"The Gray Sheet" May 6, 2002, p. 10). The Cleveland company had started a modular PMA submission for the pivotal trial indications, but the process was halted following receipt of a December 2000 application integrity policy (AIP) letter from FDA (2"The Gray Sheet" Jan. 1, 2001, p. 5). Gliatech claims it "has substantially completed its obligations" under the AIP and is "working toward the revocation of the company's AIP status." The firm has retained Adams, Harkness & Hill to manage the auction...