I am thinking your first point is exactly what the market SHOULD do- and if this statement of "Pivotal Trial" is stated somewhere- then I think it is a good possibility that it will be a human safety study. Is this point stated in their PRs??
But you may be on to something with point 2- North Korea, and all other threats bypass the above.
But in normal approvals, human efficacy data must be presented to the FDA- But not in this case.
Human Safety studies can be done in both animal efficacy studies and routine pharmaceutical products.
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