Thanks Sam81, I see this huge Wainwright point:
"Key takeaway: Amarin can use all information, not just ANCHOR. We see two key victories within the details of the ruling
about what Amarin can and cannot do, and in our view, one is more important than the other.
First, Amarin is allowed to
communicate truthful information about Vascepa’s trial results, .e., communicate complete efficacy data from the ANCHOR
study (what would have been Amarin’s label expansion prior to the AdCom massacre in Oct 2013).
Second, and, in our
view, more importantly, Amarin is allowed to communicate scientific information relevant to the potential of EPA in improving cardiovascular outcomes. This means that Amarin will be able to show doctors the ANCHOR study on one hand and the JELIS
study on the other, making a direct connection between TG lowering and the reduction of risk of cardiovascular disease. We
believe that the Street is underestimating the importance of this dual allowance: in perspective, had Vascepa been approved
in the ANCHOR indication in late 2013, Amarin would have not been able to promote the new label with any claims on CV
outcomes, whereas now it can, courtesy of Judge Engelmayer."
Anchor study in one hand, followed up by JELIS, with subgroup graph in the other hand showing 53% CVE reduction. This is something I've never seen before in a medical study, 53% reduction cardiovascular events. First thing many Doc's will think about is "..maybe this Vascepa can help my Diabetic patients. What's the risk benefit ratio, no side effects?, hummmmm..."
