If the FDA regs actually require clinical trials, the very best they could hope for is to get some sort of damages (IMO, the FDA cannot be forced to approve a drug that hasn't been tested according to guidelines), but governmental immunity would likely apply and all MNKD would have accomplish is to really get them mad and spend a horrendous amount of money on lawyers. Perhaps they thought, like they thought about other things, that it wouldn't take this long or cost so much money.