There was no mis speaking about the use of the drug in Japan or other countries. Actually each country has it's own version of our FDA. I know since my implants had to be approved by each individual countries system before they could be sold there, even though the data was the same.....pain in the rear to say the least. The proper phraseology is that in other countries Irressa has passed their respective regulatory approval process...which it has in some. Our FDA can be maddeningly slow sometimes, but you have to remember that their charter is to protect the American public from things which are not good for us, including poorly tested drugs. Compare this to the ADA, who many think is there to protect the American public's dental health. That would be way wrong, their charter is to protect their constituents...and that would be dentists.