Hi Itsa,
because we have Phase 1 results that have been successful and the concept is to trial in humans for the first time whether it's safe, I believe that we shouldn't have to repeat them again as long as the dose parameters were not exceeded.
That is just my opinion, regulators can do as they wish, even if its non-standard.
But rationale suggests it would bypass Phase 1.
Ann: Trading Halt, page-163
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