Amarin Corp Plc (AMRN)

[KCSVEN]

That would be nice, unfortunately they are asking
1)Is it Safe: Yes
2)Is It Effective: Yes, FDA reviewer argues less effective than study shows due to atypical placebo effect but still effective at what it does
3) The kicker: Is what it does safely and effectively worthwhile in regards to reducing cardiac events. If not known should we wait for Reduce IT.

I'm convinced the panel is independent and smart and the way the question is framed leads to an easy yes vote. The discussion is slightly different than the question. The question asks based on safety and efficacy should we approve before Reduce IT. If the panel takes the question at face value its a unanimous yes. If they take the question as a need to guess Reduce It Outcome and determine a vote then we get a split panel.

However the way it is questioned is an easy yes because based on safety(Completely safe) there is no reason to wait for Reduce It. Even the FDA will not say we are 100% sure Reduce It will fail. Unless someone is 100% sure Reduce It will fail there is no reason to deny Anchor expansion since it is effective at what it does and has zero side effects.

The tone of the FDA presentation will be crucial, if they really push the panel to say
1) You must come up with a percent of expected success for Reduce IT
2) If under 50 you should vote for waiting

Which they won't come out and say but if they phrase things that way we get a split vote. Otherwise we get a near unanimous decision.

Will be interesting!!