Now that Afrezza has crossed the regulatory finish line, MannKind Corp.'s task is to find a partner willing to take on the large Phase IV safety trial that is required by FDA - and that may be necessary to support adoption by doctors and patients.

After a five-year regulatory journey that included a complete response letter followed by two new Phase III trials, FDA approved Afrezza inhaled insulin on June 27 to improve glycemic control in Type I and II diabetics (see "Afrezza's Journey," page 6).