In addition, with respect to the common drug review, they'd be best to answer that question. However, my personal experience with them indicates that, for the most part, that timeline includes appeal process timing, so they may be better to address that.
From the time it receives a notice of compliance until the time they make their recommendation does also include an appeal process. If within that appeal process the manufacturer does not meet the timelines, then that further delays it.
But I'm sure they would be best suited to answer that question for you.