Resub next year, add another delay or two, and it will be next year this time before final approval.Sorry to say, though they will eventually get it done, its dead money for at least a year.I'll hold, only b/c its long term money.
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.