Replies to post #75403 on Innovation Pharmaceuticals Inc (IPIX)

[biodoc]

Every lesion must show greater than 20% reduction. Yes, the topic has been beaten to death (guilty). Bottom line: Brilacidin looks really, really good.

On a different note, I am especially intrigued by B-OM and B-opthalmic. IMO, brilacidin for these two indications should move through trials fairly quickly and my level of confidence is very high for both indications. B-opthalmic also represents a very well defined licensing opportunity that is easily carved off from the rest of the brilacidin platform.

I've been in and around the biotech space for many years and Cellceutix is by far the best opportunity I've seen in a long, long time. Mid six figure position.

[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.

[KMBJN]

Where does it say no patients required rescue medication?

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

The PR says no such thing, as far as I can read. They merely defined "clinical success" as 20% reduction in lesion from baseline size 2-3 days after first dose of study drug, and not requiring rescue treatment. Isn't it possible that 10% of B patients had a 20% reduction in lesion size, but the infection was somehow worse (redder, more purulent in the middle, etc...) and rescue medication was required?

I don't see anywhere that says nobody required rescue medication. It's just one part of two of the definition of "clinical success." We simply don't know how many had 20% reduction, and how many required rescue medication. If they failed either requirement for clinical success, then that patient was a clinical failure.