I agree Evil, the FDA like any other government regulatory agency have requirements and regulations applicants have to adhere to. There are no there to help, they are re there to guide, regulate and request what they need in terms of data, data formats and paper work needed to provide approvals. We had fast track designations from them in the past so if somebody think they are there to jeopardize us is a lie.
I just hope we are on track to provide what they need so we can move forward and up.