|>>VALENCIA, Calif., Nov. 10 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD - News) today announced at the CIBC World Markets Fifteenth Annual Healthcare Conference that it recently held an "End of Phase 2" meeting with U.S. Food and Drug Administration (FDA) officials to discuss the Company's Technosphere® Insulin System, which is under development to administer insulin by inhalation for the treatment of diabetes mellitus.|
Dr. Wendell Cheatham, Corporate Vice President and Chief Medical Officer of MannKind Corporation, said he was pleased with the FDA meeting, commenting that "the discussions focused on our plans for pivotal Phase 3 clinical development of the Technosphere® Insulin System, which is expected to include two years of safety data from a subset of trial patients with type 1 and with type 2 diabetes at the time of submission of a new drug application."
"MannKind completed its current U.S. Phase 2b study in October and we will present the final efficacy and safety data from that study to the FDA in the coming weeks. We plan to begin a series of Phase 3 and special population studies in Europe and in the United States. The first ex-U.S. Phase 3 trial is planned to begin by year-end, and the first U.S.-based Phase 3 study is planned to begin by mid-2005," Dr. Cheatham added.<<