Hey Pineapple, I'm thinking we will probably be finalized Shortly before the FDA talk whipsaw was talking about happens...then the government will have their dog and pony show followed by a few examples for other companies to follow in regards to a template...I could be wrong but I think we will be one of those template companies and that is why AVXL is so quiet...It has been my experience in life that those who speak the loudest are the most full of s$$t....and the guy sitting in the corner observing holds all the cards...generally speaking in regards to most public displays, loud is weak and quiet is strong...