The company have successfuly made a few submission - all of which were accepted.
Would be extremely unusual for the FDA to NOW say the response is incomplete, or for the company to not address an item raised int eh CRL. Actually neglectful in my opinion.
Fear not - on track record it has happened 0% of the time - so I think it's 100% FDA will acept the resubmission.
Dec 28th is my guess at the PDUFA date.
Australian newspaper article, page-204
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