Replies to post #279881 on Amarin Corp Plc (AMRN)

[Whalatane]

Bouf. There is IMHO almost zero risk re approval in the EU . It will be approved . Vascepa is a very safe drug and there’s obviously a medical need.

As to timing ... there is some speculation that AMRN will “ slow walk “ the approval .... delaying as long as possible the start of the 10 yr EU exclusivity .... hoping to have the appeals decision before they finally sign off on terms / plans for the EU .

AMRN had stated previously they would announce which path to pursue ... sell rights , partner / royalty sales or a hybrid ... in Q3

The most conservative estimate I have read re EU value ( royalty payments only ) is about 40% above where AMRN currently trades

Kiwi

[HDGabor]

B-

earliest: recommendation for approval by EMA by end of June ... approval by the EU by late August / early September (if Amarin answered the 120-day letter before end of April and no Phase 3 process)

"standard"#1: recommendation for approval by EMA by end of September ... approval by the EU by late November / early December (if Amarin will answer the 120-day letter before end of June and no Phase 3 process)

"standard"#2: recommendation for approval by EMA by end of January 2021 ... approval by the EU by late March / early April (if Amarin will answer the 120-day letter before end of June and Day-180 letter before end of December and Phase 3 will exist)

latest: recommendation for approval by EMA by end of June 2021 ... approval by the EU by late August / early September (if Amarin request extension of time - to reply - in Phase 2 and Phase 3 also and Phase 3 will exist

risk: after US and Canada approval ... 0.000000%. It is a question of when only.

Best,
G