Additionally even in the failed studies some subsets showed a reductions in CV events. FDA did not dispute this. Maybe this is about Obama care....or maybe the FDA thinks the life insurance business is just to profitable. Gotta love socialism
That wasn't the terms of the SPA, nor has any 'demonstrative medical studies' overturned the relationship between high Trigs and CVD. Jelis and the latest study analysis of EPA's are the most definitive 'science' about EPA therapy. Yet this panel, due to the nature of the FDA question(which was not phrased to coincide with the SPA objectives & endpoints) was confused and directed to a different evidentiary focus. Just look at how confused members were and how defensive that 'sponsor did everything that the FDA asked and performed the SPA objectives'.
THIS HAS TO BE CHALLENGED