3. Will the third time be the charm for Afrezza?
While there are plenty of other biotech firms that will find out results from phase 3 studies in 2013, I would be remiss if I didn't include MannKind on our list. The company has been down the road to FDA approval before with its inhalable insulin Afrezza -- twice.
MannKind's first attempt to gain approval for Afrezza met with rejection in early 2010. The FDA needed more information, including how the company's newer MedTone inhaler compared to an earlier version used in clinical trials. MannKind supplied more information, but the FDA failed to approve Afrezza again in 2011.
This time around, MannKind seems to have all of its ducks lined up in a row. The company has two phase 3 trials under way and has worked closely with the FDA to make sure any questions are answered. MannKind expects to announce the results in August. Positive findings would probably lead to a partnership deal for commercializing Afrezza, long-awaited FDA approval -- and a big boost for MannKind's shareholders.
http://www.dailyfinance.com/2013/02/13/3-events-biotech-investors-need-to-watch-in/