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What challenges await potential partner for MannKind's Afrezza inhaled insulin
Monday, July 28, 2014
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.
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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