Not as such but:
"Rather than using phased clinical trials, companies will have to demonstrate efficacy in pilot studies of as few as ten patients in one study, if the change is dramatic enough, or a few hundred when improvement is more marginal."
Unfortunately (yes this is a bit more speculation so please feel free to disagree) I don't see a pilot trial on 5 people producing such groundbreaking results that they convince the governing body. This would mean they will have to move on to a much larger trial, akin to a phase 2, before being granted marketing permission.
I really don't think so. Companies don't set up and start human trials without input from appropriate regulatory authorities. I'm confident that the company had to work with the appropriate Asian regulatory authorities to determine the size and scope of the trial. If the company is doing a 5-person trial then I believe that must be what the regulatory agency has told the company it will require.