MannKind’s Long, Winding Development Road Ends In Approval Of Afrezza Inhaled Insulin
This article was originally published in The Pink Sheet Daily
Firm now faces the commercial gauntlet of establishing an inhaled insulin in the crowded diabetes market.
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FDA’s unusually specific request suggests continued worries about safety of MannKind’s inhalable insulin; large trial (8,000-10,000 type 2 diabetics) has a variety of goals.
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Among other things, new FDA review will test whether the company has proven that data with an old device can be applied to the new inhaler the company plans to market. MannKind is not expecting an advisory committee meeting.