The event: FDA approval decision for Intermezzo, a sleeping pill designed for people who wake up in the middle of the night.
The timeline: The FDA approval decision is expected on or before July 14.
The stakes: Intermezzo's active ingredient is the same as what's found in the popular sleeping pill Ambien although at a lower dose and formulated to dissolve easily under the tongue. What makes Intermezzo unique and somewhat risky is the proposed indication as the first-of-its-kind prescription sleep aid for people who wake in the middle of the night but cannot fall back to sleep. To get Intermezzo approved, Transcept must convince the FDA that the drug can be packaged and used correctly to reduce the risk of dosing errors or impaired next-day driving ability.
Select the service that is right for you!COMPARE ALL SERVICES
- $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
- 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 + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV