Raising the cash would help MannKind support its continuing efforts to win regulatory approval for its inhaled insulin treatment Afrezza (insulin human [rDNA origin). In January the US Food and Drug Administration (FDA) rejected Afrezza and asked for two more clinical trials.
MannKind and the FDA have now agreed on the design of the two clinical trials. A study in patients with type 1 diabetes has begun and a trial in type 2 patients is imminent. MannKind expects to end both trials next year and submit data to the FDA by early 2013.