Innovation Pharmaceuticals Inc (IPIX)

[GreenBioAnalyst]

The timeline for P2B from Dec to September doesn't make sense for this to be just a phase 2b trial based on population enrollment. The original March made sense. And if the U.S. enrollment is the same as RUSSIA's sequela(e), why then staggered two different dates internationally? Then you also run into a having different SOC being given for severe in the US v. RUSSIA with Bril.

So the results have to be released soon for this P2b month from Russia ( whether it's M or M/S or not)by next week or so, to possibly justify a phase 3 enrollment that has already begun last Feb in the US? But no details were given yet at that time because the FDA hasn't released the new FDA guidance for therapeutics. IT WAS NOT UNTIL last Monday when they released it.

Unless it's only for Severe P2b cv patients here in the US, and it would require only two arms that started on Feb 1, 2021. If that's the case, results have to be out by mid-May. So phase 3 FOR SEVERE, WILL ONLY TAKE FOUR MONTHS and it has to start in June start date and be done by September? That's enough time with two arms: placebo and severe.

A phase III enrollment for both M AND A here in the US and ending in September is plenty of time to enroll 400 patients and monitor all 28, 42, or 60 days mortality rates for all three arms.

Thoughts?





THIS IS A VERY GOOD CONUNDRUM.