Replies to post #248291 on Amarin Corp Plc (AMRN)

[HDGabor]

(Relevant) Events in 2020:

March
- Day 120 Opinion by EMA (if no question ... target date: March 26)
- Trial decision

April
- Response to Day 120 list of questions on or before April 24 (TBC) … it is the earliest deadline after March 26 … Amarin will have three to six months to answer the list of questions

May
- (Week 19 … TBA): Q1 2020 (10-Q and CC)

Q2 Direct to consumer branded advertisement launch in U.S.

June
- Commission Decision (based on Day 120 Opinion by EMA on March 26, target date: June 1)
- Day 180 Opinion by EMA (if no more question ... target date: June 25)
- Response to Day 180 list of questions on or before June 30 (TBC) *
* Please note: used exceptionally and after agreement with the Rapporteurs when minor issues remain which allow the applicant to respond shortly after the CHMP list of questions and the Rapporteurs to assess the responses within a shortened assessment time.

July
- "Special" Day 210 Opinion by EMA (target date: July 23) *

August
- (Week 32 … TBA) Q2 2020 (10-Q and CC)
- Response to Day 180 list of questions on or before August 18 (TBC) … it is the earliest deadline after June 25 … Amarin will have one to three months to answer the list of questions.
- Commission Decision (based on Day 180 Opinion by EMA on Jun 25, target date: August 31)

September
- Day 210 Opinion by EMA (target date: September 17)
- Commission Decision (based on "Special" Day 210 Opinion by EMA on July 23, target date: September 28) *

November
- (Week 45 … TBA): Q3 2020 (10-Q and CC)
- Commission Decision (based on Day 210 Opinion by EMA on September 17, target date: November 23)

Q4 (TBC): Chinese MARINE trial result

Best,
G