Thanks @adreamer, great summary. One tiny thing I'd like to add...

Thanks @adreamer, great summary. One tiny thing I'd like to add is that MT did mention in one of his Q&A sessions that the 210 figure MAY change depending on the Phase 1 results. Well, these were outstanding so there may possibly be some wriggle room. But with those results I doubt they'll need it.

IMO the USA part of the trial will be the Healey Platform. I doubt that they'll hunt around for other sites in America.

My hope is that with Berry fighting in our corner and pushing along the ODD decision with the FDA we have a chance of a quick turnaround. Hopefully Cashie is right and we get it by the end of this month, that would be perfect!