By its regulations, the FDA is required to respond within 30 days as to whether it will remove or maintain the clinical hold.
“While we believe the submitted data is sufficient to release the hold and resume our clinical trials program on CX717, that decision is ultimately one that will be made by the FDA,” said Dr Roger Stoll, president, CEO and chairman of Cortex.
Cortex said that it had met the timeline it defined at its annual shareholder meeting in May 2006 for conducting additional toxicology studies required by the FDA and its submission of the complete response to the agency by early September.
Prior to the clinical hold placed on CX717, Cortex had reported positive results of a phase IIa study for the treatment of adults with attention deficit hyperactivity disorder.