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I've seen it done by Pfizer in 3 months - from the date they got the letter from the FDA to resubmit - to the date they got the approved letter from the FDA.That isn't to say that this one will be as easy, but it CAN be done.
That's pfizer, these yahoos? I don't think so.Management always poopoos how minor these cmc issues are, and then they drag on for month after month. Re-validations are time-consuming.Not to mention another plant inspection will likely required.