Just some quick thoughts on the news of the day:
People need to understand that the FDA often approves drugs based on "Prevailing Science", that is, the consensus among those in the field as to what is best for patients.
Statins were approved in this way, they did not need Outcomes evidence that some say are a prerequisite for Vascepa. If Statins had to wait for evidence from Outcomes studies, many patients would have been left in the cold. Read about statin evolution here http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SelectionsFromFDLIUpdateSeriesonFDAHistory/ucm082054.htm
There are other examples of FDA approved drugs that have been approved on prevailing science and are still under going Outcomes studies.
I think the Niaspan failed trial is what most in the field are holding up to Vascepa, vis-a-vis Trig reduction, HOWEVER, people need to OVERstand that these outcomes trials had patients with low baseline Trigs...
It is more difficult to show improved Outcomes when your patients are ALREADY in a healthy zone... That is why Amarin PRd the REDUCE-IT enrolling milestone saying the intend to keep the BASELINE over 200mg/dL trigs.
If you smoke 10 cigarettes a year and you cut it down to 5 cigarettes a year, you won't see much difference in overall Outcomes or adverse effects, If you cut 365 cigarettes a year to 182 a year, you would probably see a more healthy set of lungs. Apply the same to the baseline Trigs, a drop from 150mg/dL to 120mg/dL is not as important as 400 mg/dL to 320mg/dL.
Disclosure: I am long AMRN.