the China issued heart patent has nothing to do with the FDA Orphan Drug status of the EB trial. That patent means little, cuz there isn't any money for a heart trial. Something is going on behind the scens with EB and the FDA Orphan Drug dept. There is precident for them okaying approval based on a phs 2 trial, for an Orphan designated drug, if it warrants. WHY did the FDA change the trial wording/design? Look. Feb 6. FDA had results IN HAND! We don't.