king - i know you meant 2010 not 2012. If not we are in big trouble. I don't think the 30, 60, 90 days holds much water any more with the FDA. My opinion is that Dean gave us all he knows. He is really waiting for a response because the FDA has everything they asked for at this point. If any additional information is needed to be clarified I know it will be minor in nature cause if it was anything of major consequence it would have been addressed by the reviewer a while ago.