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): FDA approval decision for the weight-loss drug lorcaserin on June 27. 3. Vivus (VVUS): FDA approval decision for the weight-loss drug Qnexa on July 20. 4. Amarin (AMRN): 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 http://twitter.com/adamfeuerstein. >To submit a news tip, send an email to: firstname.lastname@example.org. Follow TheStreet on Twitter and become a fan on Facebook.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
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.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
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.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV