Masila stated after the AGM that Don answered what is below on the US Patient question during Q&A.

"US Patients in trial?  Don't need them.  FDA agrees (see earlier comments).  Need to match ethnic makeup of US.  We've done that.  Big cost savings" 

General360 on Stockhouse gave a detailed rundown Sept.18 on the Q&A and posted the answer from Don below about US patients.  

Q – Do we need any US patients or have any in the trial?
A- We do not need US patients in the trial, we have that formally approved by the FDA.  Thanks for bringing that up.  A lot of people think that ‘oh you need 50% or 30%.  You need. ZERO.  You need to match the ethnic makeup of the United States which we have.  With our Oriental population, with our South African population, Middle Eastern, Hispanic, we have the right mix which they agreed.  That was a big cost savings, because even just cranking up those centers which we did, even that portion is expensive.  When you have to start doing new drug labelling and drug distribution networks throughtout the US, that type of stuff, that can get pretty expensive, so in June when that approval came in , I was the happiest guy on the planet that day.  Big big move for us.