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11/22/19 11:34 AM

#252799 RE: hyperopia #252600

hyperopia, it looks like the CBER (this will be the center NWBO would have submitted to) timeline is the same... "up to 60 days".

So give or take: 60 days. The question that remains is when was it actually submitted?

One should also note that this Manual dates back to 2013.



page (36)

https://www.fda.gov/media/85790/download