Actually, the studies didn't include people with Advanced ALS, so nobody knows how advanced-stage PALS would respond. The FDA approved the drug for all PALS, but insurance companies, for the most part, are covering only those who meet the inclusion criteria for the Japan trial...thus excluding those more advanced. I don't fault the insurance companies for having restrictions like this, but my wife (who is well advanced) would like the opportunity to see how it may benefit her. After a great deal of leg work and time, her insurance company denied coverage. We have appealed the decision, but don't hold out much hope. I am also realistic, and wonder if it wise for her to take the drug should she be approved. She is determined to do so, so perhaps we will see...