Ann: BTX 1503 Acne Phase 2 Study Results Presentation, page-353

I have been working all day, so have not had a proper chance to respond. Here is my very novice breakdown. I have tried my best here, but like everyone else, I have more questions than answers.

OK. So, this slide to me, self-explanatory when you add up all the data.

This slide, however, is not. Having a look at the 5% BID has me thinking what some have already brought up, it is not the vehicle has been tainted, or the batch, or any other crap. There is a statistical error here. Switch them around and it makes sense. My thoughts, either someone has stuffed up the labelling of the actual vehicle and confused it with the 5% solution, or, someone has mislabelled the actual column in SPSS or whatever program they have been using. When you switch them around, it makes more sense, and in fact, the US results outperform the Australian results.

What about this? Well, it seems, the 5% BID is not as effective in treating the non-inflammatory lesions as the 5% QD. This is interesting. Why? I have no idea about how more CBD effects non-inflammatory lesions compared with inflammatory ones (with less CBD). Even with the high vehicle response from the US side, results overall were still statistically significant. This is fantastic!! Imagine if the vehicle response did not skew the data, the p-value would be a hell of a lot lower (maybe even p=<.001). Huge!

Finally, this beauty. It is hard to explain what is going on here. It seems for the 2.5% QD and 5% BID, there is a clear difference in the percentage of lesion reduction between Australia vs the US. There is also a clear difference between the number of lesions reduced in the 5% QD compared with the results shown as a percentage. The high vehicle difference as before. Something has gone wrong with labelling or statistical analysis/data collection/column labelling/something.

Overall.

What about individual differences? Have these been accounted for? What about the differences in environments? Winter vs summer vs autumn vs spring? Were things like cortisol measured in order to ascertain differences in stress levels? All of these make a difference.

I don’t buy the batches crap; it does not make sense. What I do buy, is either someone has mislabelled, or someone has screwed the statistical analysis.

Let’s say the batches 11x5 was the anomaly, would they not have completed a statistical analysis taking the differences in the batches into account? Surely, they would have!! And if they had, do they not now have the Holy Grail of delivery systems and Acne treatment??

Conspiracy theory – someone botched this. MC steps down, bring in Vince and his mates, raises $40m for everything else before phase III announced, no conclusive data from psoriasis released, the little/big resolution in the AGM related to $300m MC, and now these results. Now set-up beautifully for one of the cheapest CR’s you will ever see for a company going into a phase III trial. I smell a rat.

Of course, DYOR and this is all IMO.