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Re: TC43 post# 4692

Thursday, 04/27/2017 10:39:51 PM

Thursday, April 27, 2017 10:39:51 PM

Post# of 44784
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.

I go with Door #ONE... :(