This Day On The Street
Continue to site right-arrow
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
Cramer's Action Alerts PLUS - See his portfolio and get alerts BEFORE every trade. Learn more NOW!

Play TheStreet's FDA Drug Approval Contest

BOSTON ( TheStreet) -- Let's add to the summer fun with a spur-of-the-moment FDA Drug Approval Contest.

Those who have participated in the past know the drill: Your challenge is to correctly predict the outcome of key FDA regulatory events. For this summer contest, the focus will be on four drug approval decisions and one advisory panel.

Here they are:

1. Onyx Pharmaceuticals (ONXX): FDA advisory panel for the cancer drug carfilzomib on June 20.

2. Arena Pharmaceuticals (ARNA - Get Report): FDA approval decision for the weight-loss drug lorcaserin on June 27.

3. Vivus (VVUS - Get Report): FDA approval decision for the weight-loss drug Qnexa on July 20.

4. Amarin (AMRN - Get Report): FDA approval decision for the prescription fish-oil pill AMR101 on July 26.

5. Onyx (again): FDA approval decision for carfilzomib on July 27.

You have three outcomes to choose from for each drug-approval decision:

1. Full Approval: The big win, meaning the drug is approved and can be marketed for sale immediately.

2. Complete Response Letter (CRL): The FDA has some concerns or issues (incomplete data, labeling, risk management, etc.) that prevent the drug from being approved immediately. In other words, the drug's approval is rejected or delayed for some reason.

3. No Decision: The FDA chooses to extend the drug's review time, i.e., pushes out the approval decision to a later date.

For the Onyx FDA panel on June 20, predict whether the vote will be positive (recommendation for approval) or negative (recommendation against approval).

To play in the contest, please submit your predictions for all five FDA events using the "Add Comment" button found at the top or bottom of this Web page.

IMPORTANT: All entries must be submitted by 6 am EDT on Monday, June 18.

Good luck!

--Written by Adam Feuerstein in Boston.

>To contact the writer of this article, click here: Adam Feuerstein.

>To follow the writer on Twitter, go to

>To submit a news tip, send an email to:

Follow TheStreet on Twitter and become a fan on Facebook.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

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

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
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.
Submit an article to us!
ONXX $0.00 0.00%
AMRN $2.34 -2.09%
ARNA $4.37 -2.46%
VVUS $2.46 -2.38%
AAPL $124.43 -1.54%


DOW 17,776.12 -200.19 -1.11%
S&P 500 2,067.89 -18.35 -0.88%
NASDAQ 4,900.8850 -46.5560 -0.94%

Partners Compare Online Brokers

Free Reports

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