One of the biggest decisions on the FDA's calendar this month will have to wait at least a few more weeks. Regulators say they'll need four additional weeks to finalize their decision on MannKind's Afrezza, an inhaled insulin device that has stirred equal parts of passionate support and deep skepticism.
The skepticism has been more than evident among the large ranks of short sellers holding company shares. Reuters reports that close to a quarter of all its stock is held short, in anticipation the shares will be hurt by a rejection. But supporters held sway on Tuesday as MannKind shares spiked 11 percent on the news of the delay. Some investors saw this latest delay as a hopeful sign of a looming approval. At the very least, regulators weren't ready to automatically reject the inhaled insulin treatment.
MannKind's quest for an approval hit a hurdle in March, when regulators turned back its app in search of additional information. MannKind responded in July.
- here's the Reuters story