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iwfal

06/10/07 11:52 PM

#4244 RE: walldiver #4236

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.

Concede the point. It all depends on how significant the 483 is. The non-disclosure of the 483 could be a significant issue. But I don't buy the any-483-is-worthy-of-disclosure theory.