Amarin Corp Plc (AMRN)

[exwannabe]

Re: diabetic lable

Your points all make plenty of sence.

It would be possible for the FDA to have that as an option, and not bother to bring it up at the AdCom. Reason being it might have effected the ability of the AC to give advice on the question they wanted answered. Often people (even experts) will not properly weigh a hard decision if you give them an easy out.

Such a lable change could happen "in-line". The FDA often tweeks the indication at the end of the process.

The diabetic subgroup was stat sig for lowering trigs. Generally, subgroup analysis is strongly frowned on for showing efficacy because it gives one too many shots on goal. But that is not the case here, they would just be saying that the drugs lowers trigs in that group just like the others.

This sounds like the most logical compromise that could be in play.