Amarin Corp Plc (AMRN)

[rfj1862]

Can someone with knowledge of SOC change/updates please comment on how rare it is to see SOC updated this quickly and before FDA approval (or even submission!) for the recommended population?

This seems absolutely unprecedented.

The diabetes guidelines update once yearly on a regular schedule, and incorporate the latest advances each time they update. So this is not unprecedented at all. But that doesn't mean it's not amazing!

What you do not see very often is a recommendation this strong right from the start. They usually start with a lower confidence level and after some years and confirmatory trials the evidence grade increases.

This indicates that the group of KOLs who were responsible for this guideline felt that REDUCE IT was very well designed, and they have a high degree of confidence in the data. This is almost as important as the recommendation itself.

Most importantly it very strongly suggests that this drug will be approved easily.