PLX presentation @ citi. CEO clearly said three specific things 1. FDA is not at all concerned about safety and because of this reason FDA is allowing commpassionate use in US. 2. no new trial is required. 3. will try to make this process of FDA approval as fast as possible. http://phx.corporate-ir.net/phoenix.zhtml?c=101161&p=irol-EventDetails&EventId=3772256