Friday, August 09, 2019 12:34:38 PM
That's the point. Once everyone get's their legs back under them from the "surprise" reality will begin to come into focus.
Vascepa is one of the most researched, tested, and safest advancements in Cardiovascular health in a generation.
My bet is the main issue unresolved is MOA and does it matter?
Does lowering TG prevent ischemic events? Is TG the cause? The answer is no. Loveza lowers TG but does not reduce ischemic events. So then how did Vascepa do it?
IMO they want to argue, analyze and debate around this subject. There will be hypothesis around inflammation and TG as a "marker". They will go back and forth but in the end given 2 things Vascepa's label gets expanded.
1. Vascepa's safety profile is incredible. This elevates many concerns.
2. Reduce IT is a CVOT not a search for the MOA. The trial getting a 25% RRR, is statistically inline with the earlier Jelis study with no Placebo getting a 19% RRR.
Bottom line, it's safe and 100% it delivers benefit at a substantial rate and patients and care givers need greater access to it.
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