Ann: BTX 1702 Rosacea Study Approval, page-15

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30/03/21

11:01

Post #: 52135638
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Originally posted by triage: ↑

Hi Deadlifts - I would think safety and tolerance are exactly the primary endpoints you would expect from a Phase 1a trial. I think more to the point is what concentrations of CBD they will be testing. As some poster quite insightfully suggested the other week, the company already knows that at 5% and 10% concentrations CBD is safe and tolerable but maybe, for the benefit of the acne product as much as this product, they want to see what happens if they bump the concentration up to 15% or 20%. I can't see in this announcement what the two levels of concentration will be but I suspect that other poster was spot on.

If this trial shows that at say 20% CBD the product is safe and tolerable, even if it does not prove a clear winner when it comes to rosacea - and in no way am I saying it won't be shown to have an effect - they can use the primary endpoint success here on whatever they decide to do with the acne product's development. That, I would guess, is why they are holding off on the next step of the acne product development until they get the results of this trial.

The other point I picked up is that this is a very robustly constructed trial. I think there was some frustration that in the antimicrobial resistance trial the patients were not required to do a wash like apparently was required in other similar trials. It would have been an easy enough extra step but without it Botanix could not show how good the results were. Also, I'm not sure where the stuff up in the previous acne trial was but the US results in that trial again muddied what they could say. So, a big tick for this trial being robustly designed.

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