With two positive Phase III studies for inhaled insulinAfrezzaunder its belt, MannKind Corp. thinks it finally has what it takes to win FDA approval – but the company is already turning its attention to planning Phase IIIb/IV trials that will provide evidence to make a case for the new concept in the highly competitive diabetes market.
Described as an “ultra-rapid acting mealtime insulin” by its maker, Afrezza has traveled a long regulatory road. The drug has...