A more likely timeline is Afrezza two years away from another FDA approval decision, perhaps more. Call it 2013, and that's assuming the two new Afrezza studies yield positive results. Longer delays could be in the cards if the new Dreamboat device underperforms the older MedTone device. And what if FDA still has issues or concerns with Afrezza's safety or efficacy regardless of the device used to deliver it? Conceivably, FDA could have approved Afrezza based on the phase III data generated by the older MedTone device. The agency didn't do that, a fact MannKind hasn't adequately explained.
Mann might be rich but he can't bankroll MannKind forever. At the end of the third quarter, Mannkind had $98 million in cash and a credit line of around $100 million. An equity funding arrangement with Seaside, which the company has used recently to bring in more cash, is turned off with the stock trading below $6.50 a share. The company also carries about $460 million in debt.
At its current rate of spending, MannKind runs out of money in the third quarter. If spending ramps higher due to these two new clinical trials, MannKind could be forced into a series of highly dilutive stock offerings to keep the lights on. After all the setbacks and losses, Mann is going to need more than bravado and resume of past business successess to convince any sensible investor that Afrezza has a golden future.
--Written by Adam Feuerstein in Boston.
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