Amarin Corp Plc (AMRN)

[HDGabor]

Just for 'fun':

Jenkins pointed out the logistical difficulty of going back and re-visiting previous approvals. “A system that required the agency to revisit every prior decision as science evolves and standards change would make the regulatory process impossibly cumbersome and burdensome on both the agency and sponsors of approved indications.”

I would like to add: "A system that required the agency to remember every prior decision would make the regulatory process impossibly cumbersome and burdensome on the agency"

Since, after the referred studies and after Vascepa's SPA rescission they are STILL approving ANDAs with active ingredient: niacin or fenofibrate.

So once again, the three study results were 'enough' to rescinned Vascepa's SPA, but not enough to withdraw previous approval AND NOT ENOUGH to deny ANDAs ...