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Re: Bouf post# 279881

Friday, 06/12/2020 8:12:39 PM

Friday, June 12, 2020 8:12:39 PM

Post# of 426138
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

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

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