Replies to post #37052 on Amarin Corp Plc (AMRN)

[ziploc_1]

You have failed to mention that there are two courts here. One is the federal court system and the other is the court of public opinion. The court of public opinion may influence the FDA to move more quickly to rectify an obvious injustice than the time line you have put forth.

[jessellivermore]

Dear HD:

Please understand if I accept your time lines and your conclusions, then I would be compelled to agree with you.

The fact is I do not agree with either your time line, nor your reasoning. You need to go back and read the terms of the SPA..Please point out the part to me that says Vascepa must show "validated" surrogate endpoints. I am interpreting your statement to mean 15% trig lowering combined with no substantial elevation of LDL-C must be proven to show significant CVD reduction in statin patients.

The SPA was very simple ..run ANCHOR..show trig and LDL-C results..this was signed off by the FDA. Then plan FDA approved REDUCE-IT..sign up about 4000 people...FDA signed off on this..No mention in the FDA of a requirement to prove REDUCE-IT would lower CVD risk..In fact if that was known, why bother running the trial?...The FDA's exception (right to abort) was based on new substantial issues re safety of efficacy. The drug is safe and there never was any high level proof that trig reduction would lower residual CVD risk in statin patients. So stating a well known fact does not constitute "a new scientific issue re: efficacy"..Its just old news.

You keep mentioning how long it will take if the FDA appeals the court decision..Well the FDa still has to fork over the money even if they appeal..The appeal process is to get the money back..

You keep talking about business. Well I ran Boston Cosmetic Center, the biggest cosmetic practice in Boston for 30 years...So please do not think I know nothing about business.

Warm regards...":>) JL