Cephalon Myotrophin

Executive Summary

FDA Peripheral & CNS Drugs Advisory Committee will revisit Chiron/Cephalon's NDA for Myotrophin (mecasermin) for treatment of amyotrophic lateral sclerosis April 9. The committee has considered the drug twice before, once at the Treatment IND stage and once at the NDA stage, and both times said that another study would be required to support approval. Cephalon has refused to invest more in the project prior to approval. The meeting will take place at the Bethesda, Md. Holiday Inn beginning at 8:30 a.m...