Amarin Corp Plc (AMRN)

[sts66]

What BS! So AMRN ain't the first to get screwed with retroactive decisions after all - this part is just insanity to me:

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.”

IOW, we're too lazy to comb our drug database and write letters to big scary BP telling them we're yanking prior approvals or forcing them to change labels. What a crock! How is that "protecting the public"?!?!

BTW, they did get limited approval in June 2013:

http://www.drugs.com/newdrugs/fda-approves-vibativ-hospitalized-patients-bacterial-pneumonia-3824.html