As a fed gov agency that has it's approvals followed globally one has to ask who they actually represent.
Do we need a drug that is 10,000 times more potent than morphine?
Do we need a drug 10x more powerful than one that is currently killing 150 people every day?
And why do the DoD need a pill this strong? Who are they going to give it to and why?
or is this all about money? In which case the FDA has some serious questions to answer in regards to the need for it to exist.