I believe it is not a reg, GMP is GMP, it is a company decision based on eliminating any potential for variation and depends on their comfort doing so.
But I also don’t want to get into a word for word discussion of regs, it’s not why I come here and is not where I’d want to spend my time. I realize that many have their opinions. My read if relevant updates and guidance is that they could be far along already. I am not predicting a date, I simply believe the FDA has tried to make scale-up at this stage not as burdensome as it once was.