Innovation Pharmaceuticals Inc (IPIX)

[frrol]

Both your points are correct. Though there was little doubt about it given the FDA's clear criteria, it shows that OM therapies can meet eligibility for BTD. And if we don't get it, it is because the FDA thought our mid-trial didn't show a strong enough efficacy signal yet. There could be several reasons: (1) small sample size for good arm, (2) inadequate overall results, (3) concern about the ineffective arm... All three are related of course.

So we'll see. It's the FDA's call. I suspect we did show good enough efficacy to merit a Phase 3. Given B's low systemic absorption through mucosa, the FDA will be further inclined for OK'ing a P3.