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biosectinvestor

02/25/22 8:18 PM

#446984 RE: hyperopia #446610

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.