"TormenM" emails a question about MannKind (MNKD) and its inhaled insulin device Afrezza:
Thanks for the March calendar of biotech events. How do you see MannKind setting up for the FDA panel on Afrezza?
Last fall, MannKind CEO Al Mann and CFO Matt Pfeffer were telling investors an FDA advisory panel for Afrezza was "extraordinarily unlikely" based on feedback from the agency's review staff. Today, we're 26 days away from an Afrezza FDA panel. Interesting reversal.
Maybe MannKind totally mis-read the situation and FDA always intended to convene a panel for Afrezza. Or, maybe some time between last fall and January, MannKind received feedback from the FDA suggesting the agency had serious problems with the new Afrezza phase III data. MannKind, desperate to rescue Afrezza from a third rejection, then asked FDA to schedule a panel -- something drug sponsors are allowed to do.
Either way, I think you should expect the FDA panel for Afrezza to be volatile. These gatherings are rarely coronations and the data from the Afrezza phase III studies (as described to us by MannKind in press releases only) are pretty hairy.
One of my 2014 biotech stock predictions was an FDA rejection of Afrezza.
The results from the two phase III studies announced this summer were barely passable. In Type 1 diabetics, Afrezza was numerically worse than Novo Nordisk's (NVO) Novolog. The study met its primary endpoint -- barely -- only because MannKind set a low bar with respect to the statistical non-inferiority endpoint.