Seriously? So, Joe Blow mad scientist cooks up something in his lab and submits an application for trials to the FDA. And because in his application he doesn't indicate that there is a very good chance that the subjects will grow a foot out of their head, the FDA automatically approves the trials on his word? They just want him to work out the little details of how much of this fabulous new treatment he has concocted will be distributed?
OK, yup, I am game for that.
Sometimes, you just have to walk away, let the dust settle and look at it all from a different perspective.