US Placebo Results Don't Seem Possible, page-15

What's it's showing [in my limited view], is that the US version of the BOT drug was not as potent as the Oz version - whatever the control was, it was a just a control and will not therefore have consistently impressive data.

Obviously, to get approval from the US DEA to use the Oz version, we first need the OK of the drug safety regulator, the US FDA, hence the "little journey" this post PhII is now taking us on. The DEA will not give the green light based on anything less than the FDA been happy to use the Oz version. Hence i) do the trial, ii) show likely a superior performance in Oz, using the more uniform standard drug [with safety] iii) seek FDA meeting/get FDA approval to use Oz version in USA iv) take FDA agreement to DEA - changes its rule to allow production of Oz version for USA PhIII trial.

That's what I'm picking up on....so a good nights sleep ahead, once the market picks up on this, we should only see green...IMO. Might take a day or two the drama merchants like to shoot off first.