FDA delays PDUFA date for MannKind's Afrezza by three months – April 7, 2014

In a one-sentence press release this morning, MannKind announced that the FDA has delayed the PDUFA date for Afrezza by three months to July 15, 2014. The press release states that the delay will give the Agency "time for a full review of information submitted by MannKind in response to the FDA's requests." We were not at all surprised to see this news after leaving last week's advisory committee - this is in line with expectations given in our full report of the advisory committee day. Indeed, the day's discussion left multiple unanswered questions regarding labeling including indication, pulmonary function screening requirements, dosing, etc., all of which will certainly affect the positioning of Afrezza in the treatment paradigms of type 1 and type 2 diabetes. With those issues in mind, the two-week turnaround between the April 1 Committee and the original April 15 PDUFA date was virtually impossible. The delay, which would have been expected by partners as well, will push out partnership discussions; a deal would not be expected to be signed pre-approval at this stage. The company's 4Q13 call suggested financial resources will last "until at least 3Q14," meaning the current runway may or may not last the company to a partnership; we would expect future funding to come from Mr. Mann. Some form of approval seems likely at this point, though questions noted will certainly impact / "make or break" the drug's potential on the market (e.g., labeling noted above, reimbursement, and post-marketing studies).