Yesterday, the FDA staff released their review on Mannkind's (MNKD) inhaled insulin product, Afrezza, which will be subjected to Adcom review on Tue, Apr 1. The FDA staff raised questions about dosing, missing data, bronchospasms, and Afrezza's adverse effect on lung function. As I said a couple of weeks ago, I think the chance of non-approval of Afrezza is high. With today's information on the FDA's assessment, I'm even more confident that it will be miserable for Mannkind at the Adcom.
Monday will be the last trading day before the Adcom. If you also like the odds and want to play with it, pick up a few put options on Monday and wait for the fun playing out the next day. But remember, this is either a windfall or a death with your position. If I'm wrong, your put options will go to zero. So only bet with what you can lose.
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