Amarin Corp Plc (AMRN)

[HDGabor]

JL,

We agree:
- Amarin does not have to proof of CVE efficacy in ANCHOR
- FDA reason is not the strongest
- no ruling before mid-2016 (as earliest)

We do not agree (we do not have to and looks like won’t):

Meaning of SPA (including R-IT condition):
JL: award the sNDA
HDG: submission of sNDA

What is required for rescission?
JL: new (substantial?) scientific issue / evidence
HDG: determine that available info / evidence is not enough, substantial scientific issue essential to determining the efficacy

It was a breach or not, legal or illegal? – it relates to the previous one

FDA deliberately withheld information:
JL: It was to ensure Amarin would be committed to going forward with an expensive outcomes trial and FDA could release ^share the new approach earlier
HDG: FDA analyzed the situation due to sNDA submission and rescinded the SPA within 8 months.

Reason for suing:
JL: Reinstatement of SPA and claim damages
HDG: Reinstatement of SPA. (I guess to claim any damages should be a separate case and the result will be more questionable than the SPA case)

R-IT:
JL: AMRN runs the trial since it was required by FDA (part of the ANCHOR’s SPA)
HDG: AMRN runs the trial to proof V’s efficacy. (They planned the trial before ANCHOR’s SPA)

Meanwhile this summary is a “B & W comparison” a lot of area is grey (ie: timing of rescission). I think our view together is good to see the best and worst case together. (I think we won’t get the answer since AMRN will not go further with the appeal.)