Secondary Prevention label in the making with some agency verbiage similar to this:
"additional/further research is needed to grant a wider label that includes primary prevention. MOA remains misunderstood and does not explain Reduce It results in entirety. We (the agency) will work with Amarin to design a 5 year study that can help practicing clinicians understand the MOA and Reduce It results. When the MOA and Reduce It results are fully understand, we can then work towards a wider label that includes primary prevention."