Amarin Corp Plc (AMRN)

[Biobillionair]

First the FDA hasn't contacted Amarin about Anchor SPA. It would have be prudent to do so before accepting sNDA in February. At that time they could have negotiated and fulfilled any requests made by the FDA.

By accepting the sNDA, the FDA indicated (to the investing World that read SPA guidance) they where satisfied by the agreement. All failed Phase 3 of other Trig lowering drugs validate the New AACE 2013 guidelines of Trigs> 150 appears to a statistically safe level. These studies failed because average Trigs were already too low. This was covered in Ad Com.

Amarin received a negative vote because the focus was on safety, the FDA was outright negligent not to provide their assessment of safety. They could have simply provided the safety data from Marine review contain on their Website. Here: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057_vascepa_toc.cfm

Non of the Ad Com committee could accurately vote on approval without a risk/benefit judgement. You can tell none of the FDA docs prescribe, or give drugs. I would never give a drug that I didn't have a safety judgement on.

Second, committee had a majority that admitted Trig 200-500 efficacy. This precluded the FDA using the Ad Com as cover for efficacy.

Eric Coleman, after Dr. Hiatt pushed the issue, finally gave into Amarin's safety. However, this was late and after the safety of Amarin was dragged through the mud. There was no recovery at this point.

The FDA has no legal cover to revoke SPA. I believe this was there primary reason for the Ad Com.

Amarin should request AACE lipid guidelines on label, ASAP.

Calculating a hazard ratio, using adjudicated Trigs > 200, shows a significant drop in CV events.

Using a population of 70,000,000 with at risk Trig level, amounts to a potential reduction in CV events of 1.2 million per year. Very, very conservative. This translates into Billions of saved health care dollars and lives.

Risk is placebo equal.

The FDA approves drugs that show an increase in CV events!
http://www.medicinenet.com/script/main/art.asp?articlekey=173225
http://m.huffpost.com/us/entry/3854510

But specifically this drug. In the safety review document, the cardiac Hazard ratio was much higher than the FDA was going to tolerate. Nonetheless, approval with post marketing study that will likely show an increase in CV events.

http://www.cbc.ca/m/touch/health/story/1.1365168

I will request every drug with a CV risk be taken off the market in a CP quoting reviewers dating back to Vioxx.
http://www.vioxxsettlement.com