MannKind's Diabetes Device Under More Clouds
On the call, MannKind said the FDA delay wasn't a big deal because the company never intended to launch Afrezza commercially until the FDA also approved a smaller and more technologically advanced inhalation device for Afrezza later this year.
Tuesday, MannKind said it would try to accelerate the Afrezza launch timeline by asking FDA to review the newer inhalation device as part of the company's response to its complete response letter covering the older device.
Asked by one analyst if there was a precedent in which FDA allowed a company to simply swap out one device for another in the middle of a review, MannKind said the company was operating in "entirely new territory."
No wonder common sense got lost.-- Reported by Adam Feuerstein in Boston. Follow Adam Feuerstein on Twitter.
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