MannKind's Diabetes Device Under More Clouds
On the call, MannKind said the FDA delay wasn't a big deal because the company never intended to launch Afrezza commercially until the FDA also approved a smaller and more technologically advanced inhalation device for Afrezza later this year.
Tuesday, MannKind said it would try to accelerate the Afrezza launch timeline by asking FDA to review the newer inhalation device as part of the company's response to its complete response letter covering the older device.
Asked by one analyst if there was a precedent in which FDA allowed a company to simply swap out one device for another in the middle of a review, MannKind said the company was operating in "entirely new territory."
No wonder common sense got lost.-- Reported by Adam Feuerstein in Boston. Follow Adam Feuerstein on Twitter.
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