By: Adam Feuerstein | 03/06/14 - 10:14 AM EST(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?
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. Results from the study in Type 2 diabetics were more favorable for Afrezza but still, the product under-performed relative to MannKind's expectations. Afrezza also caused more weight gain in Type 2s. We still don't know, exactly, how the current "Dreamboat" inhaler performed relative to the older Medtone inhaler. And MannKind has been flinty with Afrezza safety data. We know the inhaled insulin causes a persistent cough. MannKind claims the cough is benign, but what will FDA say?I don't have much to add except to remind everyone that I will live blog the Afrezza FDA panel on April 1. Also, don't forget FDA will post briefing documents -- including the agency's Afrezza medical review -- on March 28. l'll end with a chart of MannKind's stock performance since the August release of the Afrezza phase III data relative to the biotech sector. Bearish.
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