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Re: threebabiesbusy post# 44392

Friday, 07/15/2022 10:30:40 AM

Friday, July 15, 2022 10:30:40 AM

Post# of 44695
Since the CRL sited that there were no other approval requirements, we are hoping that once the FDA inspection is complete that FDA approval will be quickly forthcoming. If the inspection occurs in July or August, I would like to think that the FDA would make a decision by the end of September (or earlier). Only time will tell.