"1st step would be starting a Phase 3 with Cephalon in Italy based on the data and results collected in Italy. Then getting DNA's "blessing" to sell it off-label here in the U.S."
Insmed can not start a pivotal ALS trial. Prohibited by DNA/TRCA settlement. They can run a Phase II with Italians but Italy is waiting on Myotrophin Phase III results before possibly sponsoring a trial.