Essentially, they think the results are great. The OZ results...

Essentially, they think the results are great. The OZ results were very significant, and frankly, a home run. Hence why they are progressing to Ph3.

The issue was with the American results, but to skim through a lot of the waffle is that they believe it's due to a manufacturing issue on the vehicle on the USA leg. They started the trial when the company was in start-up mode, using a manufacturer which was quite new (from what I can tell).

The issue in the SP is the statistical significance only on the US arm due to the high vehicle effect.

Supposedly, the non-inflammatory lesions are harder to treat - and they are happy they saw that across both legs.

The results are very strong and were what they expected - in Oz....

Alternatively, a tidy up would be great surrounding the vehicle.
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On a different note, the issue I have with the data and its presentation, and maybe it is something I would like to be clarified - is why was the data presented as a mean change in inflammatory and non-inflammatory lesion count from the baseline against the placebo?

From your preliminary data for acne, there seems to be a clear difference with longer application times of BTX against the vehicle. The question being is, why was the data not presented in a manner that showed the inflammatory and non-inflammatory lesion count across a time course? I assume you will see a significant difference between BTX and the placebo post-4-weeks at various time points.

The mean data across the entire 12 weeks, given the lack of significance in the American participant data, does not seem to do the results any justice.

They (MAY) be able to change this and spin it in a different light.