Before I start let me state that I only have a very small...

Before I start let me state that I only have a very small position (even smaller now) in this and that I have a health background.

Methods
On the face of it, this seemed like a well structured phase 2 study, it was randomized, placebo controlled and double blinded.It had a good sample size and the sample was recruited from many sites. The primary end point (which is what all medical research of this nature comes down to) was clearly stated before the trial as "an absolute change from baseline inflammatory lesions at week 12".
Results
All dose groups of BTX 1503 reduced the number of inflammatory lesions from baseline. There was an average of 40.5% reduction. That is impressive! BUT, the placebo reduced it by an average of 40.1% WTF WTF (pardon the non-scientific language). That is not supposed to happen.The slides presented today, break this down into geographical regions and in Australia, placebo reduction was only 26%. The overall results were not significant for the primary outcome (not surprisingly, as you do not need a statistician to tell you that there is not much difference between 40.5 and 40.1!).
The other important data was safety (this is always an important aspect for all pharma trials). The drug appears well tolerated, but than again, this is not a surprise as most topical acne treatments are.
Vince Ippolito, President and Executive Chairman of Botanix said: “We are pleased with the overall efficacy outcomes, clean safety profile and highly significant Australian data.”

My Comments
1. Secondary endpoints are not relevant if you do not hit your primary end point.
2. Clean safety profile is assumed, nothing to blow your horn about there.
3. What is there to be pleased about the overall efficacy outcomes!
4. You cannot subdivide the data for significance after the fact!
5. If the production process was not the same in the US and Australian controls, than they should have had two arms to this study from the start. An Australian arm and a US arm. This needs serious consideration before the expensive phase 3 process begins. It is a shame this was not considered at the phase 2 stage, it may have saved a lot of red faces for management and red ink for shareholders.

Good Luck!