MannKind Corp (MNKD) Expects FDA Approval For Its Insulin Product
January 13, 2010 3:56 PM
MannKind Corp (NYSE: MNKD) said that it expects the FDA to approve its experimental inhaled insulin device "within days" of inspecting a manufacturing plant that supplies the insulin.
Alfred E. Mann , the company’s CEO, said that the FDA has so far inspected one of the two N.V. Organon manufacturing plants that produce the insulin used in Afrezza and that the company has not yet resolved discussions with the FDA over the labeling for Afrezza or whether lung function testing will be required, although he does not expect testing to be mandated. The CEO added that MannKind expects to secure a partnership deal for the product in a number of months.







