It is likely that the mid-cycle review occurred already, and on around 6/28 (~3 months into review for priority review apps), we agree. However, only FDA knows this, and there is rationale in guidance for not holding the mid-cycle review, and deferring it for a later date. That is, if an extension to the PDUFA date has been determined as necessary before the review occurred:
It is yet another possibility to consider. Though we think more likely that the mid-cycle review occurred and that the mid-cycle communication will take place within two weeks from that date, or sometime around/by 7/12 for Amarin’s sNDA review, although somewhat later is of course possible (into next week).
On the rest, we would refer you to our CP submission that covers the issues you raised extensively, in particular pages 45-55: