This is not about blame. This about an effective problem solving process (or not) being established(developed... written)and used by the FDA. I know of many really smart/hard working FDA people. They are really usually very good at doing what they are told to do, that Is their job. Look at the historical results in CNS disease for last two decades. Look at the chart posted by Xena. Review/watch the link posted by Investor2014. This is not a friggen game.