Replies to post #298827 on Amarin Corp Plc (AMRN)

[CaptBeer]

Thanks G! This answers the question that I've had for a while: When the clock stops for responses, does it stop for a specified time, (i.e., 30, 60, 90 days)? Or does it stop only long enough to get the responses back?

Apparently the latter.

Thanks again!

[Whalatane]

HDG. thx for this timeline

Kiwi

[lizzy241]

HDG, today johnking posted the EMU time table for Sept. 14-17, icosapent ethyl appears on page 16 section 3.2.13 the date of 3.26.2020 shows as last correspondence, 180 days from that date implies that Amarin's reply is due by Sept. 26. Is that correct? If so, would that change the timeline?

[circuitcity]

Appreciate it as always, really think you can do a better job than JT.

[Biobillionair]

Could see relevant EU actions this week:

(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.

[Biobillionair]

Could see relevant EU actions this week:

(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.

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