Ampligen rintatolimod regulatory update

FDA's Arthritis Advisory Committee will meet on Dec. 20 to discuss an NDA for Ampligen rintatolimod to treat chronic fatigue syndrome (CFS). The NDA has a Feb. 2, 2013, PDUFA date. The double-stranded RNA antiviral agent that agonizes toll-like receptor 3 (TLR3) has Orphan Drug designation in the U.S. The company announced the tentative meeting date last month. ...