Amarin Corp Plc (AMRN)

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VuBru and AVII ( if available) It certainly was a pleasant surprise to me that the ADA, included both the Secondary Prevention ( SP ) and Primary Prevention (PP) population in their urgent SOC.
If one looks at the R-It data the SP benefit was clear however the PP benefit CI just crossed unity. While R-It was not specifically designed to test PP per se, one can argue that a separate PP study would be required to validate the benefit in the PP population.
I am not sure precisely what reasons ( although I am glad they did ) led ADA to include both populations, but if one looks at the robustness of the data with 7 zeros after the decimal point in the p value for the 5 point MACE, and the consistency in benefits with numerous secondary endpoints including the most evasive CVE of CV mortality, one can perhaps understand how the ADA may have concluded to include the precise dermograhics of R-It in the ADA SOC, designating it the highest level of scientific standard ( level A ).
It is possible that the FDA is trying to wrap its head around whether the indication should only include the SP or both SP and PP and to address the importance of this question an ADCOM may have been the most reasonable pathway to resolve this important question.