I believe you are correct Bear as far as US patients. I haven't looked for when he said it but I seem to remember Don stating that they didn't enroll any US patients. I think he said that the FDA looked at the cross-section of people used at the many sites around the world and there was a good enough representation of the population within those other sites. It was then decided to not enroll US patients as the approval was so late that it would have extended the trial time. I hope I have this correct but you know oldtimer's memories!