Amarin Corp Plc (AMRN)

[johnking29]

RSQUIRREL: EXCELLENT FIND!

FDA's Advisory Committees: Legal Implications of Procedural Irregularities and Scientific Disagreement

Click here for the abstract: papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID1640343_code1510466.pdf

You can download the entire document once you are there.

Has this been posted previously?

Please pardon any duplication. I don't recall seeing this before.

http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1640343

Click "Download Report" on the right side of the page...


Extremely interesting reading...

In short: We are not going to Sue the FDA and win anything because the FDA has every right to keep to Application open and ask for further testing exactly as they did in the AdCom meeting... They played out their cards exactly as I am sure they were directed to by Higher Up's and their Legal Experts...

With that said: The FDA CAN and SHOULD negotiate an Approval for Vascepa in Anchor...

“To reduce triglycerides and other lipid and lipoprotein parameters…”

...without saying (per Eric Coleman)

"...ostensibly reduce the risk of cardio vascular disease"...

There never has been an argument from the FDA that Vascepa is not safe and effective in reducing triglycerides and other lipid and lipoprotein parameters yet they said Amarin cannot use this drug to ..."reduce the risk of Cardio Vascular Disease!"

I've said since the beginning that the argument is simple:

Let the FDA win the fight yet we win the war and get the Anchor approval basically for the same reasons why we asked for it in the beginning:

To treat people with High Trig's (150 to 499)...

ALL of these arguments that the FDA is out to KILL Amarin, the FDA is against us (blah blah blah) are getting old...

For anyone who feels I am wrong, read the entire linked attachment and you will get the gist of what I am saying...

IT IS EXTREMELY REVEALING IN WHAT AMARIN (and the general Public) CAN and CANNOT DO TO THE FDA IN THE SITUATION WE ARE IN!