News Focus
News Focus
icon url

HDGabor

12/25/19 10:30 AM

#237117 RE: Burn Sanderson #237041

B-

Do you think Amarin intentionally delayed the EU submission to defer having to make a decision on an EU partner (and also to maximize their value to a potential buyer?)

Yes … as / considering:
- EMA moved from London to Amsterdam in March (e.g.: "Europe’s drugs safety watchdog anticipated in summer 2018 that around 30% of its existing 900-strong workforce would not make the move to the Netherlands, but that figure has now been revised down to 24%" … it isn't recent, it is a Nov 2018 estimation)
- pediatric waiver
- requested "priority review" (was denied)
- "clear" / close as many possible "issue" in the US

Best,
G