VALENCIA, Calif.--(BUSINESS WIRE)-- MannKind Corporation (Nasdaq:MNKD) announced today that its End-of-Review (EOR) meeting with the U.S. Food & Drug Administration (FDA) is now scheduled to be held on May 4th. Last Friday, in order to prepare for a potential shutdown of non-critical government operations, the FDA cancelled its internal meeting to prepare for the EOR meeting regarding AFREZZA, necessitating a cancellation of the EOR meeting itself, which had been scheduled for April 15th.
Mr. Mann, Chairman and CEO of MannKind commented, “We are pleased that the Agency has come up with a prompt solution, allowing us to continue preparing to implement their input into our planned studies. Fortunately the new schedule results in only a brief delay. We will continue working with the FDA to complete the regulatory process for AFREZZA.”
About MannKind Corporation
MannKind Corporation (Nasdaq:MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. Its lead product candidate, AFREZZA(R), is in late stage clinical investigation for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia. MannKind is also evaluating an investigational cancer immunotherapy product, MKC1106-MT, in a phase 2 clinical trial. MannKind maintains a website at www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.
This press release contains forward-looking statements, including statements related to future interactions with the FDA, that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Company's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, difficulties or delays in seeking or obtaining regulatory approval and other risks detailed in MannKind's filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2010 and periodic reports on Form 10-Q and Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
Matthew J. Pfeffer
Corporate Vice President and
Chief Financial Officer
KEYWORDS: United States North America California
INDUSTRY KEYWORDS: Health Biotechnology Oncology Pharmaceutical Research Diabetes FDA Science