I could accept this idea if the Phase 1B trial for BTX 1204 was run in the US, but it was only Australian based which means they probably used the same manufacturers as in the Phase 2 BTX1503 Aus arm of the study which did show clear separation from the vehicle for the Aus data.
This Phase 2 study for BTX 1204 is set up in the same format as the Phase 2 BTX1503 study where there is a US arm and an Aus arm (and a NZ arm which will be interesting to see those results).
Botanix have said they are using different manufacturers for the US arm of the Phase 2 BTX1204 study than what they used for the US arm of the Phase 2 BTX1503 study so we just have to hope that the issue arose from the manufacture of the vehicle for the US arm of the Phase 2 BTX1503 study and that it has been resolved with this new manufacturer.
From all the info Botanix has given out though it seems that they don't actually know what caused the high efficacy of the vehicle in the US arm of the Phase 2 BTX1503 study so it is more than a little concerning. In saying all this the analysis done by Argonaut recently has given me a lot of hope as it shows phase 2 clinical trials of other acne medications had similarly high efficacy results from the vehicle and yet they still went on to release their products to market even with substantially higher adverse effects than what Botanix's formulations have shown.
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