Well for one thing, trials will still need to be done in the US. The FDA is not going to accept Malaysian trials as the final say. They will most likely be able to use that data as part of the approval, but FDA will want 20K+ participants done under US FDA trials.

I agree Bintai is to pay for the trial costs in Malaysia, and elsewhere since I believe they mentioned trial sites worldwide, but we need the FDA IND approval and not "yes, looks ok" in the comment letters.