How I Think About MannKind's Afrezza FDA Panel
By: Adam Feuerstein | 01/10/14 - 11:37 AM EST
will bring its inhaled, rapid-acting insulin Afrezza in front of an FDA advisory panel on April 1. [Insert April Fool's Day jokes here.]
In today's Biotech Stock Mailbag
, I elaborated on my prediction that FDA would reject Afrezza. That was before the FDA panel announcement, so let's discuss further.
I see the scheduling of a panel for Afrezza as a MannKind negative, indicative of FDA's problems with the Afrezza data. At best, it's another risk that will hang over the stock until April 1.
I've always had my doubts about MannKind's ability to find a marketing partner for Afrezza, despite the company's assurances that negotiations were underway. It's hard now to see any potential partner taking on the risk of Afrezza in front of this FDA advisory panel.
This morning on Twitter, healthcare investor (and TheStreet contributor) Aafia Chaudhry @aafiac argued the scheduling of a panel betters the odds of Afrezza approval, in part because 1) FDA almost never approves a diabetes drug without first holding a panel; and 2) A panel endorsement is absolutely necessary for a unique product like inhaled insulin. She implies that historically, experts on FDA panels have been more lenient and supportive of new diabetes drugs than the FDA itself.
Aafia's points are well taken but on balance, I still see more risk to MannKind because the Afrezza data are a black box. The only data investors have seen come via MannKind press releases. In April, we'll get a far more objective -- and critical -- take on the Afrezza data when FDA posts its review ahead of the April 1 panel.
I expect the FDA's briefing documents to raise a lot questions about the efficacy and safety of Afrezza. I think we'll also learn a lot more about the interactions between FDA and MannKind over the last several years, some of which won't put the latter in a favorable light.
I'm really looking forward to live-blogging this FDA panel. April 1 can't come soon enough.
-- Reported by Adam Feuerstein in Boston.
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