Replies to post #28644 on Amarin Corp Plc (AMRN)

[HDGabor]

Yes and no.

Yes: Vascepa could be THE anti-inflammatory drug, but it's a new sNDA.

No: The problem is the FDA determined that a substantial scientific issue essential to determining the safety or efficacy of the drug in the BD on Oct 11 2013. Not in 2010 (Accord-Lipid), not in 2011 (AIM-HIGH), not in February 2013 (sNDA submission), not in March 2013 (HPS2-Thrive). It is fact and not interpretation.

Of course – top of this – their background / reason – is wrong due to several reason (other studies’ target group / type / side effect, etc.) as it’s discussed on this board, so I am not repeat it again.

So the FDA 'has to' protect both the background and the timing, 'as a matter of public policy and fundamental fairness to the sponsor, FDA should be accountable for continued diligence in identifying issues that bear on the continued enforceability of a SPA agreement and in notifying the sponsor of such issues within a reasonable period of time after FDA becomes aware.'

[drrc1949]

Actually BioChica, one of the significant problems here is that AMARIN has been primarily focused on Triglycerides rather than Inflammation.

The truth is that they've been privy to more than three (3) years of education by members of this and other expert boards demonstrating that inflammation is the problem. There have been more than ONE HUNDRED studies, many posted by Zumantu (thank you!), that illustrate how Vascepa works at a metabolic level that includes, but is not limited to, reduction of TGs (these have all been forwarded to Amarin). I wonder when or if ever Amarin could be expected to learn SOMETHING....AND ACT!!!....instead of allowing every other "johnnie-come-lately" to steal the thunder!

It's an outrage and I've probably stayed involved way too long to still remain objective. JZ was a paper tiger, JT is a neanderthal....he sounds like one anyway. Wonderful representation at Jeffries.......again.