It has been available in the U.S. by prescription for years, you have seen advertisement after advertisement, for prescription drugs only on an hourly basis. We have two FDA cleared products for two years, and no exposure. We are "NOW" educating Dr's in the UK because of NHS putting us behind the counter. The reason for not advertising of not having funds and waiting for FDA full clearance is bogus hogwash. we have four years left on the Patents, and we still continue to piss into the wind with the FDA. There are "NO" excuses left.