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MannKind Corporation's Date With Destiny

Editor's Note: MannKind's PDUFA date is July 15th -- it was accidentally noted as June 15th. The Fool regrets the error.

MannKind's (NASDAQ: MNKD  ) PDUFA date is July 15, so we'll be watching carefully to see whether the Food and Drug Administration will approve its inhaled insulin Afrezza.

This isn't the first time the drug-device has been up for approval. The company changed the device portion of Afrezza before the last review, which led the FDA to request more clinical trials. MannKind ran the trials, which both came back positive.

If approved, Afrezza will compete with injected mealtime insulins from Eli Lilly (NYSE: LLY  ) and Novo Nordisk (NYSE: NVO  ) . One of the clinical trials showed that Afrezza was non-inferior -- clinical-trial lingo for the same or better -- to Novo Nordisk's Novolog.

Slam-dunk approval, then?

Not so fast.

While the FDA advisory committee recommended the agency approve the drug, the agency has the final say and doesn't always follow the panel's advice. Considering that the FDA's briefing documents sent to the committee trended toward the negative side, an approval isn't a foregone conclusion.

Watch the following video for more thoughts on the potential approval of MannKind's Afrezza from senior biotech specialist Brian Orelli and health-care analyst David Williamson.

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Read/Post Comments (5) | Recommend This Article (5)

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 June 11, 2014, at 7:55 PM, keshi wrote:

    its not this sunday june 15, it's on july 15 . i think you got it confused.please correct it otherwise all investor will get confused.

    thank you

  • Report this Comment On June 11, 2014, at 7:56 PM, mbracket123 wrote:

    Umm, you don't even have the right month for the PDUFA date - its July 15.

    And you obviously didn't watch the adcom or you would know there is no way the FDA wont approve. They had so much egg on their faces and there was such a ground swell from the experts and patient-base that it is highly unlikely it won't be approved. Labeling is the only question and even there only minor wiggle-room is available, and it will be insignificant to the market opportunity.

  • Report this Comment On June 11, 2014, at 9:39 PM, missjessiecat wrote:

    Mix-up on dates aside, this guy is just not very impressive! I wouldn't listen to him! But......BUY!

  • Report this Comment On June 12, 2014, at 8:22 AM, cuda wrote:

    "While the FDA advisory committee recommended the agency approve the drug..."

    Not only did the ADCOM recommend the drug, they recommended the drug 27-1.

  • Report this Comment On June 12, 2014, at 9:09 AM, surfish wrote:

    This stock is going to make the shorts cry.

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Brian Orelli

Dr. Orelli is a Senior Biotech Specialist. He has written about biotech, pharmaceutical, and medical device companies for The Motley Fool since 2007.

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9/3/2015 10:57 AM
MNKD $3.84 Down -0.01 -0.26%
MannKind Corp CAPS Rating: **
LLY $82.57 Up +0.76 +0.93%
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NVO $55.53 Up +0.18 +0.33%
Novo Nordisk CAPS Rating: *****