RE:Where is the FDA application for the Phase II trial? When you file with the FDA, you go with money in hand to pay for the trial, fees and such for the FDA to do their part (likely to be in the mid- to upper- $100,000s US) ...so, got a spare $million or so sitting around gathering dust? No? Then don't bother wondering any longer why the FDA submittal hasn't been made. Reread the "forward looking" portion of the company's PRs.