My uninformed guess would be that approval rests o

My uninformed guess would be that approval rests on results found within the scope of the trial protocol they approved and the results outside of the protocol they set would be not considered, if they're as strict as the US. Perhaps with our established safety profile the data would still be relevant to Brazil, the PI or India, but that's only a guess on my part. Good questions for a future PR for Nader and Dr. Kelly as they work with them through the trials.