US Placebo Results Don't Seem Possible, page-13

As explained in another HC thread - apparently, the US "DEA" does not allow the same type of BOT drug as was used here in Oz - PhII are learning trials, so BOT answered an important question before they head into a PhIII - ie, we need to twist the arm of the DEA, to allow the Oz version of the BOT drug to be used in the USA too, as the study also showed the Oz version was safe. IF this is all true and it sounds about right - then we had actually a very successful and informative PhII.

Obviously, BOT need to be a little sensitive in taking this point forward with officialdom, so it's cloaked in "cotton-wool" a little in the Press Release. IF they were a little clearer with this point, it would have smoothed things a little with investors. ie, "we liked the Oz drug version better and subject to DEA approval, THAT's the one we likely will be taking forward". Experience is of course, never speak for a govt agency before it's all agreed, hence BOT took the only path they currently can.