Innovation Pharmaceuticals Inc (IPIX)

[BonelessCat]

The primary outcome is not at all ambiguous in the way you suggest. Each patient must achieve at least 20% lesion reduction with no other interventions. So, in a 205 person trial there are 205 3 day response tests. That's where the ~90% number comes from for each arm at 48-72 hours.

Early clinical response [ Time Frame: 48-72 hours after first dose of study drug ] [ Designated as safety issue: No ]
The primary efficacy outcome, early clinical response 48-72 hours after the first dose of study drug, will be determined in the ITT population. A subject will be considered a Clinical Success if 1) the lesion area has decreased by =20% compared to baseline and 2) no additional systemic antibacterials that are potentially effective against gram positive organisms have been administered.

And, I agree, the no rescue statement is very significant.

As a general rule I enjoy ambiguity. In this case I find it annoying because because I have seven figures riding on it.

But I digress.

At the risk of murdering a fine point, something generally best left to others...the primary endpoint definition is ambiguous at best.

If it means that EVERY PATIENT must show 20%+ lesion reduction in under 3 days, then I am surprised any drug would ever meet that tough of a standard. Yet this is the literal interpretation of the protocol.

If it means that THE AVERAGE lesion reduction must be 20%+, then it leaves way too much room for wiggling. For example, one way to achieve average lesion reduction of 20% is for 20% of the patients to show 100% reduction and 80% to show nothing at all.

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One other point...No patients required "rescue" treatment. That in itself in a very significant outcome.