MannKind Corporation
Afrezza
type 2 diabetes
Date
TBD
FDA decision · Date TBD estimated
What's at stake
An FDA complete response letter on Afrezza for type 2 diabetes is in focus around Date TBD.
Primary source
· SEC 8-K
verified 14h ago
“In connection with the approval of the Biologics License Application (“BLA”) for Afrezza in June 2014, the U.S. Food and Drug Administration (“FDA”) required us to conduct a five-year, randomized, controlled trial in 8,000-10,000 patients w”