Unfortunately, looking for innovation from a government agency full of bureaucrats (15,000) who have no threat of losing their job is a lost cause. It’s incredible a drug which has been known for years to be safe is jumping thru more hoops than large Pharma drugs which have under-whelmed. Add to that , the politics of a small drug company which may have a massive impact in saving lives, struggles to get the attention it needs to get to market quickly