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Tuesday, 09/10/2019 8:33:47 AM

Tuesday, September 10, 2019 8:33:47 AM

Post# of 425944
18 Days to PDUFA !!!! Let the countdown begin! What you say - PDUFA is delayed and there is an AdCom? Says who? The only person we have heard from is JT and he was told to keep it under his hat. And we don't even know who at the FDA informed him - was it a janitor who overheard something? There has been no formal announcement of delay or scheduling of AdCom by FDA. It's a rumor until we hear from the FDA. I think this is another under promise and over deliver tactic by JT. "They talked about a delay with an AdCom but we were able to work with them and get it approved under the normal timetable without the need for an AdCom".

Can anyone tell me who at the FDA contacted Amarin and how did they make contact (i.e. phone, email, letter, telepathy, etc.)
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