Amarin Corp Plc (AMRN)

[jessellivermore]

Will..

The FDA is not going to appeal any legal action for the simple reason they lack the knowledge regarding the medical and scientific background information of the drugs. That has been the problem from the beginning. FDA simply has nobody who is an expert on n-3 and their effects on the eicosanoid system or for that matter the cardiovascular system. The last thing they want is more exposure to their ignorance.

A tip-off to the way FDA does business is the way they focus in on "outcome trials". Early in med school an analogy of understand medicine was put in terms of navigation. One way to navigate is to memorize the coastline, the second better way is to learn to use a compass. FDA has no compass. Outcomes trials eliminate all the intermediates, all the science, this is great as a true test, but it is expensive, time consuming and the results can be misleading for many reasons. Just read the Yahoo board comments on JELIS. A bunch of dummies spouting the party line without any deep understanding that parts of JELIS are very suggestive of the power of EPA..The problems arising from the numbers and the cohort selection.

That's a problem with outcomes..the process itself can effect the outcome, and if you know little or nothing about the process the more likely things are to go wrong. Just look at all the wasted effort running "fish oil" studies all of them under dosed.

The FDA needs medical and scientific experts who can research the literature to see if something makes sense from a scientific standpoint..They already have enough paper pushing bureaucrats.

":>) JL