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Re: None

Tuesday, 10/21/2014 7:32:55 PM

Tuesday, October 21, 2014 7:32:55 PM

Post# of 426181
Re: Amarin's curious delay in filing another appeal.

Without completing the FDA's 5 or 6 step appeal process Amarin can not sue the FDA in Federal Court. So without any further clarification, it would seem that the company should be filing their appeal as soon as possible; as taking this to court is a very important option, and the sooner the better.

I can think of three possible reasons they might be delaying.

The first being the FDA has given them reason to believe they are considering a label expansion, perhaps based on the quarterly DMC review of blinded data. Blinded data can yield some important information. The FDA could be leaning this way due to some recent articles supporting trig reduction.

The second being they are in negotiations with a partner with deep pockets. The partner may be willing to cover Amarin until REDUCE-IT is finalised for a cut of the action. The "partner" may not wish to antagonize the FDA and is not concerned with the time element.

The third would be Amarin itself has seen enough in the data to be confident enough about REDUCE-IT that it no longer feels any urgency to move toward legal action.

I realise some of you simply believe the company management is sim[ply too stupid or lazy to continue a process they have already "substantially" undertaken...I do not think this is the case.

":>) JL
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