Mannkind

Last clinical trials!

MannKind (NASDAQ: MNKD ) has been developing its inhaled insulin product Afrezza for years. The FDA rejected the drug-device combo in 2010, requesting additional information on the clinical utility of Afrezza.

The biotech company resubmitted, requesting approval of a new smaller device called Dreamboat. At the time, it seemed like a good idea after Pfizer's bulky inhaled insulin device, Exubera, stumbled out of the block and never recovered. Something that was even more discrete than an asthma inhaler -- compared to Exubera, which looked more like a bong -- seemed like a good idea.

Source: MannKind.

Unfortunately, the FDA wasn't convinced that the new Dreamboat inhaler would have the same clinical outcomes as the MedTone that was used in the clinical trials, so the FDA asked for additional trials.

Those two phase 3 trials are set to read out in the middle of August. MannKind is somewhat in a no-lose situation, because the worst thing that happens is that the trials fail and it reverts back to the MedTone device. That seems unlikely, though, given the data to date.

http://www.fool.com/investing/general/2013/06/21/3-biotech-companies-to-watch-this-summer.aspx