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MannKind’s Long, Winding Development Road Ends In Approval Of Afrezza Inhaled Insulin

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

Ghosts of Exubera Haunt Afrezza As Lung Function, Cancer Concerns Weigh Heavily

FDA advisory committee review of MannKind’s inhaled insulin revisits safety issues that troubled Pfizer’s first-of-its-kind product, including a potential lung cancer risk and declines in pulmonary function.

Does MannKind Finally Have What It Takes To Get Afrezza Inhaled Insulin Cleared By FDA?

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.

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