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Dreamboat sinks prospects for fast approval of inhaled insulin

Nature Biotechnology volume 29, pages 175–176 (2011)Cite this article

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The demand for more data was unexpected, as the agency had already issued MannKind a complete response letter last March requesting bioequivalence data for the devices that dispense powdered insulin. The company responded with a comparison study and assumed that would suffice. “We thought we had come to an agreement as to what would be required, so this came as a bit of a surprise. But it's within FDA's purview to [ask for more data],” says Matthew Pfeffer, MannKind's CFO.

MannKind will soon meet with FDA to discuss how to proceed. The company had already decided to conduct further trials that can now be adapted to include a MedTone comparison arm. “They were primarily intended to be marketing studies, but we have the equipment to fill MedTone inhalers,” says Pfeffer. As the trials weren't designed to include a comparison arm, that might complicate matters, but at least on the surface it appears most of the FDA's concerns could be answered.

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    Jim Kling

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Kling, J. Dreamboat sinks prospects for fast approval of inhaled insulin. Nat Biotechnol 29, 175–176 (2011). https://doi.org/10.1038/nbt0311-175

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