Several analysts have made sport of MannKind's quest to obtain FDA approval of an inhaled insulin drug. If Pfizer couldn't do it with Exubera, they reason, how can MannKind find success? And that has some predicting a significant delay for the therapy past the scheduled January 16 action date at the FDA.
MannKind, though, isn't backing down. Its president and COO, Hakan Edstrom, confidently predicted to Bloomberg that he expects an approval by January 16.
"Based on our success so far I am bold enough to say we will see an approval," Edstrom tells Bloomberg. "There are no indications by the FDA that they will not be able to come out with a final ruling by January 16."
Four of 10 analysts covering the company are telling investors to dump their stock. But not everyone thinks that MannKind is wrong to remain optimistic. Even if the FDA does delay a decision, says Rodman & Renshaw's Simos Simeonidis, a drop in the share price would be a good reason to buy. "If the market reacts negatively on such a delay," he says, "we would see any dip as a buying opportunity."
- check out the story from Bloomberg