Amarin's Anchor Gamble Sends Stock Up 20% On 'No News' News

| About: Amarin Corporation (AMRN)

Alas, just as it seems that reality and common sense could have been taking over with regards to Amarin's (NASDAQ:AMRN) ANCHOR approval without its REDUCE-IT trial results, the company finds the smallest of shreds to hang on to as it was announced this morning that the FDA is delaying a ruling on the additional indication while Amarin's appeal is considered.

The expanded pool that makes up the patient population that Amarin is going after with the ANCHOR indication is almost 10 times as many patients as Vascepa, Amarin's sole drug, is approved to treat right now. So, to say it's an issue of some importance to the company would be an understatement.

Also, to say that the news released this morning has any substance at all to it, would also be an understatement.

Amarin's 8-K filed this morning stated:

Amarin Corporation plc announced today that the U.S. Food and Drug Administration (FDA) notified the company last night that the FDA does not expect to take action on Amarin's supplemental new drug application (SNDA) for the proposed ANCHOR indication labeling expansion for Vascepa ® (icosapent ethyl) capsules on the December 20, 2013 Prescription Drug User Fee Act (PDUFA) goal date because Amarin's request to re-instate the ANCHOR Special Protocol Assessment (SPA) agreement remains under consideration with the FDA. No new PDUFA date was established.

The FDA also communicated to Amarin that it now views Amarin's appeal of the ANCHOR SPA agreement rescission and the ANCHOR sNDA as separate administrative decisions worthy of separate consideration. FDA plans to complete its review of Amarin's request to re-instate the ANCHOR SPA agreement and plans to convey its decision to Amarin no later than January 15, 2014. The FDA provided no additional information on when it expects to complete its review of the ANCHOR sNDA.

There can be no assurance that Amarin will be successful in its appeal of the SPA agreement rescission or, more importantly, the approval of the ANCHOR indication sNDA.

Immediately this morning, Amarin opened up over 20%. The stock has become a vehicle for day traders and now moves on speculation, with its sub $2 price. It's important to read the last line of Amarin's 8-K, which is in there for a reason:

There can be no assurance that Amarin will be successful in its appeal of the SPA agreement rescission or, more importantly, the approval of the ANCHOR indication sNDA.

While there is no doubt that if the company does miraculously, somehow, achieve ANCHOR approval without competing its REDUCE-IT study (due to conclude in 2016) we'd be looking at a stock run of epic proportions - it's important to note that the chance of that occurring is likely less than 1%.

As a reminder, the FDA's ADCOM panel, in October of this year, voted against recommending Vascepa for expanded label distribution - effectively relieving the stock of 80% of its value and crushing one of the biggest bull arguments behind Vascepa.

I see the delay as simply a delay of the inevitable - that ANCHOR will still rest on the shoulders of the outcome of the REDUCE-IT trial, forcing new CEO John Thero to keep his head up and get a prudent plan in place for Amarin over the next two years.

It's important to know that buying Amarin on this news is almost total speculation - and it's a scenario that would carry potential massive reward should things swing their way - the smart money is staying on the sideline until the company gets a cogent plan in place to reduce spending the next two years and set up for potential ANCHOR approval when REDUCE-IT is finished.

Best of luck to all Amarin investors.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.