They're basically saying, "hey, if you want to combine this trial's results with other critical patient results that's cool, just please submit how you're going to do that before the trial is over so we can give you some feedback. Don't surprise us after the fact."
It's a good thing because they're allowing us to take critical patients from CD12, and possibly even Philippines, Brazil, or compassionate use to combine for a broader look at how LL works.