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Re: Dancing in the dark post# 295975

Friday, 09/04/2020 5:45:15 AM

Friday, September 04, 2020 5:45:15 AM

Post# of 426074
(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.

September
- September 14-17: Day 180 Opinion / recommendation of approval by EMA (if no more issue) or List of Outstanding Issues (LoOI)

November
- November 23: EU Commission Decision / formal approval (based on Day 180 Opinion by EMA, September 17)

December
- December 23*: Response to Day 180 LoOI, September 17 (Amarin will have three months to answer the LoOI.)

January
- January 28: Day 210 Opinion by EMA / recommendation of approval

April
- April 5: EU Commission Decision / formal approval (based on Day 210 Opinion by EMA, January 28)

Best,
G

ps.:

(i) “shortest” EMA timetable in case of LoOI

- September 14-17: 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 15: Commission Decision / formal approval (based on Day 210 Opinion by EMA, November 12)

*clock restart

Notice: This post will not be updated anymore.

Disclosure: I wrote this post myself, and it expresses my own opinions (IMHO). I am not receiving compensation for it.

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