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Tuesday, August 04, 2020 8:20:47 PM
I'm right, you're wrong.
Re.
overall timeline for the review being completed by the EMA shifting from what was previously estimated as late 2020 into our current estimate of early 2021
Regarding regulatory review of VASCEPA in Europe, COVID-19 appears to have modestly slowed certain aspects of the review with the overall timeline for the review being completed by the EMA shifting from what was previously estimated as late 2020 into our current estimate of early 2021.
b.) The "exact" timeline - with some uncertainty regarding the "speed" of Amarin's reply / replies ... aka duration of clock stop - was known since December 2019. Everything (YTD) happened as were expected ... happened as listed.
All together:
- Phase III is most likely guaranteed (expected by Amarin). We will now by September "14" for sure.
- Most likely date for the Opinion is January 28, 2021 (assuming 3-months for Amarin's reply to LoOI) and approval by March (early April).
- However, Amarin could "control" the Phase III, the timing of the Opinion ... they could get the Opinion as early as November (approval in January) or as late as April (approval in June).
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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