"Look again at AMRN/Vascepa. Eleven months after reporting what has to be called a grand slam, completely blowing away their primary endpoints, they are still struggling to get acceptance."

There has been no struggle. NDA (or supplemental NDA, sNDA,in this case) applications and approvals take time. The possiblity of the FDA scheduling an AdCom was always there. It seemed unlikely that an AdCom was going to be called due to the proximity to the initially scheduled PDUFA date of late September; however, there was always a possibility for an AdCom and Amarin acknowledged this. Just because the market assumed no AdCom doesn't mean that there is a struggle for sNDA approval. Based on the AdCom, now the PDUFA date is likely to be stretched out too. Vascepa is already FDA approved for lowering triglyerides. The sNDA is for the added cardiovascular indication. 

BearDownAZ