Amarin Corp Plc (AMRN)

[jessellivermore]

ML...

The 2013 AdCom panel question went to the question of whether or not the SPA should be granted..Paraphrasing the question."Was there any actual proof, even if EPA (V) did lower trig levels, that this trig lowering would lower CVD event risk"..The answer was no..The MARINE and ANCHOR trials were not designed to measure Vascepa's ability to lower CVD event risks..These two trials were designed only to examine AMR101 (V) effects on various blood markers such as trigs and LDL-C levels..

The FDA's concern was CVD event risk..At that time the FDA was vocal in their opinion that only LDL-C levels would be considered valid surrogates for CVD event risk..

R-I was designed to answer the question of whether 4 gms/day of EPA would lower CVD event risk..And this is what the FDA requested to grant the sNDA
label expansion...

I was following Amarin at that time and was as angry and disappointed as Bb or anyone else...The FDA reneged on an SPA..which was unprecedented..And I thought congress would step in as the SPA was a congressional creature..But they didn't...and I think the reason they didn't was FDA explained that it had made a mistake in granting the SPA..The error was assuming lowering trigs would translate into lower CVD event risk..And until the R-I results were publicized...There was no proof of that being the case..

I do not believe the FDA's actions were tied to some perceived dislike of Amarin or any of its management or employees...Amarin was too small and insignificant for FDA to have developed sort of personal opinion on..FDA did not wish to grant a 35 million patient indication for a drug which might not show any therapeutic benefit..The fact R-I was positive is after the fact..If everyone knew the drug would work..Then the price would have been much higher before the R-I results were known...

I do not believe FDA will be/is out to get Amarin..As a clinician I don't think the label will have as much of an effect on what doctors will prescribe or not...And I don't think doctors need an extensive label to protect against mal-practice suits..A greatly underestimated fact is Vascepa's safety profile. The thing that holds back prescribing off label is mal practice suits...Vascepa is practically unique in just how safe it is..Though most of us cringe when Vascepa is described as fish oil...Remember it is derived from fish oil and has a better safety profile than over the counter fish oil...And I am not aware of many malpractice suits from taking fish oil...

R-I showed Vascepa had a small but significant increased risk of Afib or flutter...But more significant was V reduced the risk of ischemic stroke by 27% and the real danger of Afib or flutter is ischemic stroke..So this would be a hard sell for a med-mal lawyer...As far as bleeding is concerned there was not one case of fatal bleeding in the entire R-I trial..

All of this supports the notion doctors will be able to safely prescribe this drug for any number of indications other than those on the label...

For these reasons I am not that worried about getting a broad label...I think it will be for CVD in those on statins or statin intolerant..T2DM with a CVD event risk factor..I don't think FDA can reasonably go after the MO issue as they have run numerous trials in the past using MO including MARINE and ANCHOR...

":>) JL