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Amarin: Prepping for FDA Approval Decision

BEDMINSTER, NJ ( TheStreet) -- An Amarin (AMRN - Get Report) primer ahead of Thursday's expected FDA approval decision for the company's prescription fish-oil pill AMR101:

What time will the FDA decision be announced?

Impossible to say. We may hear in the middle of the day, like we did Friday with Onyx Pharmaceuticals (ONXX), or not until evening as with Vivus (VVUS - Get Report). If you're trading the Amarin approval decision, my best advice is to be ready for news any time after noon EDT. And don't forget that Amarin may decide to halt trading at some point Thursday ahead of the announcement.

Is there a web site I can follow to read about the FDA decision in real time?

The FDA updates its web site with new drug approvals but generally not in real time. Same with FDA's online press room.

Amarin will issue a press release, of course, but I'll be shocked if the company is first out of the gate with the AMR101 news (unless the drug is rejected, which isn't likely.)

Your best bet for instantaneous reporting of the AMR101 decision is Twitter. Log into StockTwits and follow the $AMRN feed. If/when there's real news on AMR101, you'll see it on StockTwits instantaneously. I have a pretty good track record of having a fast draw with FDA drug approval news, so you can follow me on Twitter as well at @adamfeuerstein.

What's the chance that FDA will reject AMR101?

Tiny. I'd give it single-digit odds, certainly no more than that. Investors expect AMR101's approval Thursday by a wide margin -- and rightly so. If FDA rejects AMR101, the outstanding issues are likely to be relatively easy to fix.

Will FDA announce AMR101's New Chemical Entity (NCE) status simultaneously with approval?

Not necessarily. FDA may not make the AMR101 NCE decision public until the Electronic Orange Book (EOB) is next updated, which means Aug. 10.

Amarin has stated previously, however, that FDA may announce its approval decision and NCE status simultaneously. We'll know Thursday.

AMR101? I thought Amarin changed the drug's name to Vascepa?

If we believe the marketing web site leaked Friday, AMR101's new brand name will be Vascepa. Note that Amarin has also trademarked some other possible names, too, including Amracor and Civapri. I'll start referring to AMR101 as Vascepa.

Arena Pharmaceuticals (ARNA - Get Report) and Vivus have both traded lower since their respective drug approvals. Is this what we can also expect from Amarin?

The recent trading pattern for FDA drug approvals (see Arena, Vivus) has been a short-term price spike followed fairly quickly by significant selling/profit taking. With expectations for Vascepa approval so high already, what's preventing Amarin from acting just like Arena and Vivus did?

Here's my prediction (which is probably not worth the electronic ink used to print it): Amarin shares trade up to $18-20 on approval with NCE status still undisclosed but then sell off as investors start wondering about Vascepa's launch. There's more upside in the stock -- and durable -- if approval and NCE status (five years' exclusivity) are granted Thursday, even more if Amarin announces a boffo partnership or takeout in conjunction with Vascepa's approval. Maybe that Pfizer (PFE - Get Report) partnership/takeover rumor is true?!?!?

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AMRN $2.37 0.00%
ARNA $4.31 0.00%
GSK $46.69 0.00%
PFE $34.33 0.00%
VVUS $2.35 0.00%


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