This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
See Cramer's multi-million dollar portfolio for FREE and get his new book Get Rich Carefully! Learn More

Amarin: Prepping for FDA Approval Decision

BEDMINSTER, NJ (TheStreet) -- An Amarin (AMRN) 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). 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) 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) partnership/takeover rumor is true?!?!?]

Stock quotes in this article: AMRN, GSK, PFE, VVUS, ARNA 

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
DOW 16,501.65 -12.72 -0.08%
S&P 500 1,875.39 -4.16 -0.22%
NASDAQ 4,126.9670 -34.4910 -0.83%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto
Advertising Partners

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs