MannKind Gears Up To Make Commercial Case For Inhaled Insulin Afrezza
This article was originally published in The Pink Sheet Daily
With two new positive Phase III studies, MannKind is getting back on regulatory track, with plans for a new FDA filing of Afrezza in the fourth quarter. Still, the firm is still planning more Phase IIIb/Phase IV studies to differentiate the inhaled insulin on the market.
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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.
Execs fend off criticism for taking so long to release complete response letter news, and share plan to adapt ongoing trials to meet new FDA demands. But some analysts are not convinced.
Even if Afrezza is approved with a clean label, the product would face big commercial hurdles.