Innovation Pharmaceuticals Inc (IPIX)

[FarmaZutical]

What are the expectations concerning the timeline for bringing Brilacidin to market ? If we look at Cubist and the just approved Zerbaxa which btw also got QIDP designation and priority review they published topline results late 2011. 2 pivotal phase 3s and 3 years later they got the FDA approval a couple of days ago.

Now, Cellceutix began patient enrollment for Phase IIb in February and we are now awaiting bottom-line results and a Phase III seems imminent. Obviously, Leo moves very fast but will we need one or two Phase 3s ? And how many patients will be required ? The Phase IIb enrolled 215 patients and I think a pivotal P3 will require at least 4 times that.

So isn't a PDUFA date somewhere late 2017 or Q1 2018 a fairly realistic bet for Brilacidin ABSSSI ?