Is Inhalable Insulin Assured To Be Approved By The FDA?

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If you have followed the diabetes drug market for very long, chances are high that you have run across the possibility of an inhalable form of insulin ultimately being approved by the Food & Drug Administration. This is where the controversial company called MannKind Corp. (NYSE: MNKD) comes into play. The company’s stock has traded higher after it has asked the FDA to approve its Afrezza.

What investors need to know is that Afrezza is MannKind’s inhalable insulin. Investors also need to remember that this product has been in the works for years, and prior inhaled insulin products from other companies were not approved. The approval process goes back to 2009, but the company was hit in 2011 when the FDA demanded that more clinical studies were required.

So when you see a gain of 5% to $5.38 against a 52-week trading range of $1.82 to $8.70 for MannKind shares, we have to ask if there is an assured outcome here. It seems that there is a growing belief that Afrezza will be approved. Based on “seems” we have to make the reminder that there are certainly no assurances that the FDA is going to approve its inhalable insulin.

Our understanding is that the FDA has a negative bias against inhalable insulin compared to the safety of the insulin treatments already on the market. The FDA has also proven to be less than predictable regarding many drug approvals.

MannKind is worth only $1.57 billion as of now. This could be substantially higher of Afrezza is approved. Unfortunately, that is still far from a certainty.