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One Small Step for Afrezza, One Giant Leap for MannKind

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The path to approval for MannKind's (Nasdaq: MNKD  ) key drug, Afrezza, is starting to take shape.

Shares jumped as much as 33% this morning, after the company announced that the Food and Drug Administration has confirmed two clinical studies to evaluate the efficacy and safety of the inhaled insulin treatment. The drugmaker met with the FDA on Wednesday, and clearly the meeting was a success. MannKind COO Hakan Edstrom added that the company was also "encouraged to proceed promptly with the initiation of both clinical trials."

This announcement is critical to the company, since it's a step closer to finally getting a drug on the market. The company has been burning cash, as it has no revenue and its coffers have been dwindling. But even if Afrezza finds its way to the market, it will face a host of established competitors, like Eli Lilly’s (NYSE: LLY  ) Humalog. Furthermore, Pfizer (NYSE: PFE  ) once took a shot at an inhaled insulin drug, Exubera, but promptly abandoned it because of weak sales. If Afrezza scores the FDA's blessings, shareholders can only hope that it won't suffer the same fate. MannKind has a lot more riding on Afrezza than Pfizer did with Exubera.

This stock is still a little too much of a long shot for my tastes, although the odds did get a little better with this confirmation. I'm no stranger to risk, but in this case I still think there's a little too much uncertainty. MannKind may end up hitting the jackpot with Afrezza, but I'm not planning on attending the celebration.

Fool contributor Evan Niu holds no position in any company mentioned. Check out his holdings and a short bio. Motley Fool newsletter services have recommended buying shares of Pfizer. Try any of our Foolish newsletter services free for 30 days. We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Read/Post Comments (2) | Recommend This Article (2)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On August 12, 2011, at 5:01 PM, cmfhousel wrote:

    Great headline.

  • Report this Comment On August 13, 2011, at 1:32 PM, uropa1 wrote:

    You keep posting your blog each time news comes out about mannkind and afrezza. You are not a fan of the stock and continue to state it has too much risk and that Pfizer failed w/ exubera. Why then keep posting. STFU and stop blogging about a company you feel is too risky. If there is no value in your blog if you do not believe in the company. Your blogs do make you appear biased against the stock (which you clearly state that you are) and make your intentions appear to short the stock.

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