MannKind Corporation announced today that its End-of-Review (EOR) meeting with the 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."