No, we're outside the guidelines. The guidelines are about getting stuff done within the specified review period, which in this case was a Priority Review. They just blew all that up with the AdCom decision, which normally would have been made no later than the mid-cycle review meeting.
We are in largely uncharted territory here, and the history between the FDA and AMRN is unique. The guidelines you've been referencing are helpful in terms of expectations, but the possible range of explanations behind all of this has now been blown wide open.
Anybody who says they are sure what is going behind the scenes right now, in terms of either content or timeframe, is full of it.
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