Amarin Corp Plc (AMRN)

[ziploc_1]

FDA announced PR on 5/29 with PDUFA on 9/28
FDA announced Adcom 8/8 with PDUFA 11/14

? what happened to change FDA thinking between the May PR and the August Adcom announcements
1.? FDA became aware of Amarin management request for more liberal labeling
2.? FDA decided to get tougher because of NVS scandal
3.? FDA decided to respond to Citizen's Petitions re MO or MOA
4.? FDA decided to wait for results of the Epinephrine study
5.? FDA decided that a drug like Vascepa, affecting such a huge population, needed an Adcom

I am leaning towards answer number one.