Kept reading, also found this gem - not sure it's good news - yeah, the FDA, the NIH, the AMA etc are all desperate to get the trial results to put the issue to rest once and for all, but AMRN can't afford to keep the original design w/o ANCHOR, which may torpedo getting the desired stat sig data they need:
If ANCHOR indication is not approved, FDA is aware that the continuation of this study in it's current form is subject to change
And this bit:
Development
Approval through FDA (sNDA) or courts to market results of ANCHOR trial
Again, 1st amendment issue to show docs ANCHOR data (and likely JELIS data too), does not mean ANCHOR will be on the label - they'll go for off-label scrips like Lovaza, although that makes it more difficult to get insurance coverage.
All in all, the presentation's tone says that they know they are facing an uphill battle with the FDA that they are very unsure about winning, may even be leaning towards the realization that they're not going to get ANCHOR any time soon, maybe not even until something comes out of R-IT, like great interim results, for instance, but halting enrollment pushes req'd number of stat sig AE's further out.
They're between a rock and a hard place, in limbo because the FDA is entrenched for now - and the FDA has every reason to delay, delay, delay, because without further appeal denials AMRN cannot go to court to seek justice - keeping the matter out of court is the FDA's primary course of action because they know they'll lose. And no political pressure can really help either, the FDA will point to the formal appeal process and claim all avenues must be exhausted first, which is true, whether we like it or not. Hate to say it, but this is dead money for probably at least a year or more unless something breaks the logjam, as in BioBill manages to file some sort of lawsuite that sticks.
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