"However, the phase 2 results showed the primary endpoint in reduction in inflammatory lesions did not achieve statistical significance"
Its not because the product didn't work; It's because the placebo worked just as good. Both the placebo and the product was effective at treating the acne, and the statement 'did not achieve statistical significance' is because the performance between the two was near equally awesome.
Therefore, it gave rise to the concern that the control of the placebo (which involved multiple suppliers) had been stuffed, and it was 'speculated' that the active ingredients (CBD) was also in the placebo.
Clarity never came from why, how, and who caused the placebo mix to allegedly be stuffed; perhaps litigation concerns against suppliers saw them not front up or own up? Having placebo's analysed to confirm suspicions is too expensive and to what end? perhaps the US Phase 2 bungle isn't an impedence to 'going to market', with successful Phase 2 results in Australia being sufficient to approach FDA?
If the end goal for the phase 2 was to find sufficient success somewhere to progress to phase 3, and we reached that through Australian results, then why pursue the stuffed USA trial? (particularly with finite resources).
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