Monday, October 29, 2018 12:15:26 PM
109 days total elapsed days since submission to FDA.
LESS two factors - first, the two weeks at the beginning when the submission is reviewed for completeness, at which point the FDA clock starts and, second, any hiatus caused by FDA asking questions or for clarification, during which the FDA Day clock stops, then resumes when answers are received.
Therefor, there could be 14 plus 30 or 44 days added to what is perceived by many to be 90. In fact, ignore the days and any clock, it is a guideline only. Like flying, I would rather have a late successful landing than an early failure.
Go BIEL.
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