Joining me this morning to cover the Depomed FDA panel live blog are Zacks analyst Jason Napodano and biotech investor and TheStreet contributor Aafia Chaudhry. Jason and Aaafia are bullish and bearish on Depomed, respectively, so I'm hoping for some fireworks between the two along with insightful analysis of the panel's proceedings.
The Depomed drug being reviewed today is Sefelsa, a long-acting form of the generic drug gabapentin, which is currently approved to treat shingles-related nerve pain.An FDA review posted to the agency's web site Thursday found that Sefelsa does provide some relief to menopausal women but also questioned the durability of the drug's effect. Studies conducted demonstrated Sefelsa can lower the incidence of hot flashes for four weeks but response falls off when measured at 12 or 24 weeks, FDA said. The FDA also raised concerns about Sefelsa's link to patient reports of suicidal thoughts. Experts on the FDA's advisory panel are being asked to review the efficacy and safety data for Sefelsa and vote on whether or not to recommend the drug for approval. The final decision on approval rests with FDA. The agency is expected to make its decision known by May 31. -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein
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