Amarin Corp Plc (AMRN)

[Anonymous Fish]

Surely you have to go with the scientific evidence? Thats what the FDA are all about. The primary prevention cohort suggests benefit but doesnt scream it the way the secondary prevention cohort does. The numbers are close but there not quite there for primary. The data isnt quite robust enough for the size of the patient population at risk. Thats just my opinion of how the FDA may be thinking based on what the panel members said.

My own personal views are that they should grant primary because the drug works and its extremely safe. I dont believe that it causes any bleeding whatsoever and the significant side effects are caused by other unknown factors related to the patients diet and lifestyle. I bleieve Vascepa can ONLY benefit these patients. Approve the expanded label and let the docs decide when and where it is appropriate to use ie most cases. I just dont believe thats what the FDA will do though.