Amarin Corp Plc (AMRN)

[HDGabor]

(Relevant) Events:

Dancing in the dark: If you think, please replace my previous post (sticky) with this one but at least remove the existing sticky. Thx.

(i) “standard” EMA timetable

- September 17: List of Outstanding Issues (LoOI)
- December 23*: Response to Day 180 LoOI, September 17 (Amarin will have three months to answer the LoOI.)
- January 28: Day 210 Opinion by EMA / recommendation of approval
- April 5: EU Commission Decision / formal approval (based on Day 210 Opinion by EMA, January 28)

(ii) “shortest” EMA timetable (after clock-stop for responses)

- September 17: Day 180 List of Outstanding Issues (LoOI)
- October 13*: Response to Day 180 LoOI, September 17
- November (9-)12: Day 210 Opinion by EMA / recommendation of approval
- January 18: Commission Decision / formal approval (based on Day 210 Opinion by EMA, November 12)

(iii) “shortest” EMA timetable (after immediate responses**)

- September 17: Day 180 List of Outstanding Issues (LoOI)
- September 22*: Response to Day 180 LoOI, September 17
- October (12-)15: Day 210 Opinion by EMA / recommendation of approval
- December 21: Commission Decision / formal approval (based on Day 210 Opinion by EMA, November 12)

*clock restart
** This timetable is only 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.

Best,
G

Notice: This post will not be updated anymore.