Amarin Corp Plc (AMRN)

[heysfguy]

What is FDA Thinking? Nice post - esp. the missing link idea. What we may be missing is an accurate idea of how the FDA is working these days. I don't think any large agency like FDA is in complete lock-step about anything. So the "FDA" probably isn't thinking anything.

What may be the problem - and perhaps cause for some significant delays - is that currently the FDA is undergoing political turbulence about the agency's mission and procedures. There's got to be a lot of political machinations in an agency that large.

Just a theory, but wouldn't this explain quite a few of the difficulties Amarin has experienced? The blind-siding of the ADCOM? Delays, delays, delays? And perhaps even the heightened scrutiny from the Senate?

It might also portend greater chance of reversals at the higher level of appeals for Vascepa. Certainly there is good evidence that Dr. Jenkins has had to over-rule some of these shenanigans at the lower level.

Yes, I am loyal, suffering long.