Amarin Corp Plc (AMRN)

[yellow_bluff]

Not much new from cannacord, just another opinion but its as good as anyone elses:

We expect AdComm discussion to focus on how recent NON-Omega 3
outcomes studies showing equivocal outcomes benefit relate to
Vascepa’s ANCHOR indication, and if REDUCE-IT outcomes data is
needed pre-approval. The ACCORD, FIELD (Tricor) and AIM-HIGH
(Niaspan) outcomes studies, showed no CV benefit related to TG
lowering in patients with TG’s around the ANCHOR range. We think
FDA will ask the panel if TG lowering in this population may improve
heart health. We note, however, Vascepa is also associated with
modest but stat sig LDL reductions, widely recognized as beneficial.
Even if the panel decides TG is not important, they may find Vascepa’s
total of benefit (e.g. on ApoB, CRP, Lp(a), etc.) meaningful.
• We continue to think recent large-scale omega-3 supplement or lowdose
studies will not be major topics for discussion. There has been
focus on certain investigator sponsored studies that looked at low dose
EPA/DHA therapies that showed no significant benefits to CV health.
While these trials may be mentioned, we doubt they will be major
topics of discussion or real pushback on near-term ANCHOR approval,
due to design, Tx drug and rigor.
• We see 5% chance AdComm will demand REDUCE-IT data preapproval,
95% AdComm is fine with it as a Phase 4 commitment.
REDUCE-IT will not yield data until 2016-2017. In the unlikely event
common sense and any value placed on practical drug development
explodes, we think AMRN shares will go much lower.