Agency will miss the Jan. 16 action date for the NDA due to a manufacturing inspection; but how the potential length of the delay remains to be seen.

Agency will miss the Jan. 16 action date for the NDA due to a manufacturing inspection; but how the potential length of the delay remains to be seen.

MannKind had been pushing to submit an NDA for Afresa - the only inhaled insulin still in development - by the end of February. However, the Valencia, Calif. company announced Feb. 26 it is delaying the filing by approximately three weeks to reduce the size of the dossier by "several tens of thousands" of pages to make the document more reviewer-friendly; the "back-up" data will be available if requested by FDA. Announcing the specifics for the delay may not be the wisest decision. As Diabetic Investor's David Kliff notes Feb. 27, "This statement just might peak the agency's curiosity and create the impression that there might be something in those tens of thousands of pages that the company does not want the agency to see." MannKind has been retooling the positioning of Afresa as "ultra rapid-acting" insulin to separate it from Pfizer's failed Exubera (1"The Pink Sheet" DAILY, Feb. 18, 2009)