Amarin Corp Plc (AMRN)

[HDGabor]

D-

My 'basis' was management secondary target and Lovaza's previous label (the 200-500 study was removed just earlier this year).

Boost or not? Maybe, hopefully. With data / study on label sales reps and the company will have "easier" job to sell as they could talk about ANCHOR as part of the label.

CC was not about sNDA - they definitelly said "we not share our plan regarding sNDA during this call" - but it sounds as next phase.

The question: when?

As FDA did not deal with ithe sNDA during the SPA appeal process, I hope that the management will send a letter / confirmation to FDA regarding "no more appeal", otherwise FDA will wait till Oct 11 (AMRN has 30 days to appeal). Hopefully FDA evaluated the sNDA already and "just" the label is remaining and we could see something within a 3-4 weeks.

I do not give high possibility, but
- FDA STILL not accept TG as a VALIDATED end-point - so it is just a no change as they see TG
- FDA does not have any confirmation that TG lowering therapy is NOT lower CVE - I see it as a small change compare with DMEP that said that below TG 500, therapy is not necessary as the aim within this poplation is CVE reduction and TG did not reduce CVE

Altogether, OND (FDA) current view: we do not know, "please" finish the R-IT, since we would like to know.

They will not approve the claim as it is, but at least b.) - just data/study on label - not a irreale possibility and if FDA take into account "everything" they could accept / propose / agree modified indication.

Under the current circumstances it is the best for everybody:
- AMRN could sell V in 200-500 with approved indication
- FDA could say we did not approve ANCHOR since not confirmed CVE, but we approved differently as the drug is safe and we will see at R-IT result.

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raistthemage,

No real reason to appeal:
- it was not a classical contract, it is an agreement and it just a primary base of the claim, not the one and only
- it is not slam drunk, since FDA change his practice / approach regarding lipid surrogate-endpoints and not any law or policy
- the case easily could run till mid-2017 (at that time R-IT will be stopped already or will be finished few months later) as they could submit the case around beginning of Q2 2015.

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BB,

I do not think it could be 150-500. Do not forget R-IT is also about 200-500 now, since the SPA was modified in May 2013 (min TG from 150 to 200)