Where is the data to confirm the incidence of Angina in the 1,050 patients with prior MI ( JELIS 2ndary ) ? You state that this group " had a heavy reliance on reported Angina , most of it was Angina "
You might read page 7 of the following Limitation of JELIS trial
1) " we can not exclude the possibility of bias in some of the physician initiated endpoints such as coronary revascularisation and hospital treatment for unstable Angina " 2) Use of low dose Statins 3) Under powered for analysis of subgroups ....2/3rds in trial were women who have an incidence of coronary events 2-3 times lower then men. ( my highlight )
Provided that Reduce-it is successful, what additional studies would take for a EPA/statin combination to become a reality? As a reminder, amarin already conducted a phase-I (http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=772903). So my question is what would be needed to built on that successful trial and secure regulatory approval for the combination.