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funnygi2

10/31/13 9:40 PM

#20050 RE: raistthemage #20043

My interaction with a class-action attorney. Would any others care to weigh in?

We spoke in the last ten days about this company. I asked if a class of shareholders could sue the FDA (Food and Drug Adminsitration) for their actions which may have harmed a company and you said the short answer is no.

Since our conversation, on the heels of the advisory committtee meeting that was held on Oct. 16 - and that to most followers was orchestrated by the FDA to have the committee give a "no" vote to the question of expanded labeling for Vascepa, Amarin's already-approved medication - the FDA has officially given Amarin notice that they have rescinded their previously-agreed-to SPA agreement (Special Protocol Assessment) whereby Amarin, in return for conducting an expensive, multi-year trial to see if Vascepa actually reduces cardiac "events", would be given expanded labeling. Currently Amarin is approved by FDA for patients with triglycerides above 500. Their sought-after labeling would have additionally indicated patients with trigs from 200-500, a much bigger market. This larger market would have provided Amarin with funds to continue this expensive multi-year trial. In the AdCom meeting there were no issues related to safety or efficacy, yet suddently the FDA said in effect, unless there is proof that lowering trigs actually reduces "events" then we won't approve it. This was never a condition of the SPA - the FDA only asked that such a trial be "substantially underway". The actual outcome won't be known for several years, yet AdCom members were curiously asked to vote on their personal speculation as to what the results of that trial might be, rather than simply the safety and efficacy of Vascepa in patients whose trigs were 200-499.

By rescinidng a previously-agreed to protocol, FDA has endangered the financial health of the company, not to mention actual loss in stock value to its shareholders. Amarin in good faith is conducting an expensive ongoing trial that is costing tens of millions of dollars. Bascially the stockholders have footed the bill for that trial. The SPA is generally considered to be a contract or agreement. In view of FDA's actions, as a stockholder in AMRN I ask again if FDA is liable. The following opinion was voiced on a stock message-board, unless this refers only to an action that the Amarin Corp. can take against the FDA as oposed to its stockholders....

Is FDA untouchable ?
Not if they are in breach of contract... federal law waives sovereign immunity in such cases


There are many things that are curious about FDA's new position. They seemingly have said if you have trigs from 200-499 it's no longer considered a risk factor for cardiovascular disease. This flies in the face of conventional wisdom and practice - notably the AACE (Am. Association of Clinical Endocrinologists) 2013 Algorithm (treatment guidelines) specifically states trigs over 150 (!) should be aggessively treated and specifically cite an omega3 PUFA (that is to say, Vascepa) as lowering triglycerides by 22%

You might also be interested to know that just prior to the FDA releasing its "briefing documents" to the public the Friday before its Oct. 16 AdCom meeting, an investor or investors bought 10,000 put contracts - equal to one million shares - that were well out of the money and had ONE DAY left 'til expiration. Whoever bought these contracts ended up profitting handsomely as the briefing docs put out by FDA caused the stock to fall significantly, as for the first time it raised the questions that were disussed and voted (negatively) on by the committee, suggesting that some "insider" had advance knowledge of the FDA briefing docs.

If interested I can send some you links to all this or put you in touch with doctors who can explain the science better than myself. Thank you