Even if AMRN has a "takings" case against the FDA, I don't believe they feel strong enough to take the issue to a judicial level. If so, I think they would have made a final appeal, to exhaust procedural avenues.
Like HD, I now believe our best short-term hope lies with the FDA’s upcoming response to the Senate Committee. And perhaps AMRN does, too. Here's why:
The Committee’s recent directives did not arise out of nowhere – they resulted from mounting industry concerns about how the SPA process may affect their research plans and general operations. These concerns are directly attributable to AMRN’s SPA woes.
The Senate Committee’s demands for clarification of the FDA’s policy for canceling SPA’s should point up several issues: 1) how the FDA defines a serious scientific concern about efficacy, 2) how the FDA communicates those concerns to sponsors, and 3) if the FDA is open to revising their SPA management going forward (including conflict of interest on advisory panels).
Since these issues expose the FDA to additional legislative scrutiny there is the potential, as HD has pointed out, that the FDA may regard the AMRN debacle as a procedural error.
A compromise hammered out via legislative pressure may be much faster and much less expensive than appealing to a judicial body.
And even that is the best possible scenario, if you ask me.
Even better would be prescriptions going up faster, and continuing studies prove the effectiveness of various EPA and trigliceride lowering therapies.
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