OMG....I am dealing with absolute morons here...The one guy (even2ucanbeasstupidasIam) should be in a locked ward someplace, and you're quoting me a page out of the FDA handbook. You can't infect people with smallpox to gain FDA approval. You do understand that I hope. Therefore, you must have extensive animal studies with ST-246 backed up by hopefully someone who actually received ST-246 (the one soldier comes to mind from ancient history), and then hope the FDA has enough to grant approval given the limitations of the trials.
But you cannot proceed at all until you and the FDA AGREE on a trial design (SPA). This has not happened yet with Siga and the FDA. It may in fact never happen. That is the problem in a nutshell, no pun intended to evenu2arecrazy....the "nut" part I mean.