Amarin Corp Plc (AMRN)

[ziploc_1]

I believe the decision to depend more on events studies and and less on biomarkers was made at the highest level of the FDA. Middle level managers may have been given the task of executing this policy (hence the SPA mess and the ADCOM mess) but hey were not the instruments for formulating the new policy. Thus it makes sense that any appeals in the matter of the SPA could not be resolved at the middle level. It would have to fall to the upper levels to evaluate the new science and how this would affect the policy, specifically as it relates to the case of Vascepa and Amarin, and as to whether there is any leeway for compromise here.