"Does that mean that Phase 2 data should be enough to get approval"
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The way I read it was if efficacy is strong enough we only do one Phase II trial, noting other drugs go through a proof of concept Phase IIa trial and then a further phase IIb trial, before a Phase III trial is even considered.
Progesterone, our main competitor in TBI (as far as current advancement goes) is doing a very big Phase III trial, after completing Phase IIa and IIb trials. Its results werent super exciting which I assume is why they have had to go through all the hoops.
The key thing to note is that NEU & DoD have progressed NNZ-2566 under budget and under time, compared to the average pharma... which leaves a bit of slack as far as the patent clock is concerned....
intrrepid-phase 111 trial., page-7
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