This is spot on...We are dealing with decades of process and paperwork in a large 15,000 person bureaucracy. The health agencies in other countries mirror this . There is no reward for breaking protocol and there isnt the word "innovative" when the letters FDA pop up. Being a risk taker in a government job is not rewarded. Sticking to protocol doesnt get punished as people die. They are all on auto-pilot. And the FDA feels they are the gold standard...of what ??