Amarin Corp Plc (AMRN)

[sts66]

For patients in the primary prevention cohort, there were no statistically significant risk reductions for either the primary or key secondary composite endpoints (Table 3.12)

At a prespecified alpha level of 0.15, there was evidence of a significant differential effect between the secondary and primary prevention subgroups on the primary composite endpoint (p-value for interaction=0.14) but not the secondary composite endpoint.

Can one of the stats guys explain that 2nd paragraph in English? The first paragraph says no stat sig data for primary prevention, the 2nd one says "evidence of a significant differential effect" at an alpha level of 0.15 - WTF does that mean? It also says that whatever it means it applied to 5 pt MACE but not 3 pt MACE, meaning angina and PCI's are what caused the "differential effect" to be visible.

I *think* this indicates primary prevention may not be on the label, but if R-IT data suggested something was possible (although not stat sig), maybe FDA allows the label to say something about PP. In the end, what really matters is if docs will prescribe for PP and if insurance will pay for it - what exactly did the ADA say in their SOC statement? Did they throw out a blanket rec that all diabetics should be on V whether they have established CVD or not?