I just don't understand why posters would think that the Betonmace trial would be altered because the FDA have approved it.  It is late but to change the FA to something other then the original goal of 125 events now just doesnt seem reasonable. ??? With four reviews on saftey all positive with no recommendations to change anything, I am inclined to think that Don may knows he has a winner and now is just waiting for a few American patients to be included to announce the FA results.  Just rambling, This is so out there, it boggles the mind. How long to get American patients involved? They should have been rearing to go in hope of approval from the FDA.