There are some key things to note here:
[b]Pursue Authority to Market ANCHOR Trial Results
? Primary Goal: FDA approval of ANCHOR Indication
? Secondary Goal: FDA addition of ANCHOR data to Vascepa prescribing information
Secondary Goal: FDA addition of ANCHOR data to Vascepa prescribing information
? Tertiary Goal: Judicial permission to communicate ANCHOR trial results to clinicians (1)
Cost-Effectively Advance Other Opportunities
? REDUCE-IT Outcomes Study: Important study assuming revision of labeling to reflect the ANCHOR trial (2)
? Ex-U.S. Markets: Increase level of priority, consider strategic options (3)
sNDA TIMING HISTORY
Oct 2013: FDA advisory committee voted “no” on whether Vascepa’s effects in ANCHOR were sufficient to grant approval on an ANCHOR indication prior to the completion of REDUCE-IT.(4)
PATH FORWARD
? Current FDA interaction is at Division level; appealing to higher levels
? Current FDA interaction is at Division level; appealing to higher levels
? If FDA appeals are not successful, pursue judicial relief under First Amendment
? Uphill battle but Amarin believes that patient care would benefit from Vascepa approval and also that Amarin has valid legal, clinical and regulatory arguments
– Amarin’s efforts have been supported by numerous clinicians, industry groups and elected officials(5)
1. If the FDA doesn't change their stance on ANCHOR AMRN is indicating they will go to court to exercise 1st Amendment rights to allow rep to discuss ANCHOR results with docs - falls short of them going for putting ANCHOR on the label and fighting for it in court, even if they leave CVE risk reduction out of it. Low risk strategy.
2. Appears they're saying R-IT may not go forward without getting ANCHOR data on the label - another threat to pull out of the trial.
3. Looks like they're finally going to get around to getting approval for at least MARINE in Eurozone and others, something they should have started 1-2 yrs ago. After putting all their eggs in the US ANCHOR market, which blew up in their face, they're getting on with the program - about frigging time! Realize it will take nearly a year or more to get EMA approval, something the hinted at "strategic" partner may help with.
4. It's now clear, even though they didn't say it, that they tried to get "reduced CVE risk" on the ANCHOR label. STUPID MOVE.
5. A nod to all the good work folks here and elsewhere have been doing to pressure the FDA to overturn their decision on the SPA and approve ANCHOR - note that they are aware of certain Senators being involved too - this is good stuff - means maybe there is communication between their lawyers and the Senators?
Lastly, I'm puzzled by pg 18/19 - $4B-$6B market opportunity just for MARINE indication? And $40B for ANCHOR? What are they smoking?!? Also have this little blurb at the bottom of page 18, which indicates they want to go off label with docs for CVE risk reduction:
The effect of VASCEPA on cardiovascular mortality/morbidity and pancreatitis risk in patients with severe hypertriglyceridemia has not been determined.
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