The agency is pursuing a case against Morningside because it continues to offer residential drug and alcohol treatment programs without a license, and a trial on the issue is scheduled for Decemeber.
Northfield is currently in the data analysis stage with PolyHeme and expects to report top-line trial data in the fourth quarter of this year, followed by filing its biologic license application with the U.S. Food and Drug Administration in the first half of 2007.