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Cover Story: Strategy: Partnering Afrezza

What challenges await potential partner for MannKind's Afrezza inhaled insulin

By Stephen Hansen, Senior Writer

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).

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