<<The point is - how much does it matter if they were minor points that would have gotten signed off in less than 3 or 4 months? I believe that you would have considered an approvable (or approval with a lien? - not clear to me how they would have worded it) with the only lien being something worked off within 90 days to have been a home run. I certainly would have. I understood the 'might as well give them an approvable if they have a manufacturing issue' argument but I think this is a very weak argument if the 483 is something that could be worked off in 60-90 days.>>
Yes, it would be a weak argument if the delay was only 60-90 days...but if it was minor or routine but still required a reinspection, then we are possibly talking toward the end of the year for the FDA to schedule it. That's when the "wait a few more months for 9902B scenario" could come into play.
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