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Saturday, 10/12/2013 12:42:11 PM

Saturday, October 12, 2013 12:42:11 PM

Post# of 426915
This is not necessarily the case. They will do whatever they believe to be the best interest to the public. In general, they go with the panel recommendation especially if it is one sided.

I think FDA basically would like to know whether they should approve Vascepa based on improvement of lipid parameters and whether the improvement translates to improvement in clinical outcome.

I personally believe there are ample evidence to support this issue. AMRN has to present a convincing evidence for the panel to support vascepa usage. What is clearly in their favor is that all major cardiovascular and endocrinology societies including AHA, endocrinology association, and the NCEP ATP III guidelines recommend treatment for elevated TG. They need to present the recommendations of these key societies.
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