Will Mannkind’s Dream Come True?
The CEO and major stockholder of MannKind, Inc., convinced his firm to develop an inhalable insulin, Afrezza and inhaler, Dreamboat to treat diabetes. The unapproved Dreamboat inhaler with Afrezza instead of the approved Medtone inhaler was used when MannKind filed their application in 2010 with the U.S. Food and Drug Administration (FDA). MannKind used its latest inhaler technology and the inhaler substitution delayed the approval process because FDA wanted proof Dreamboat was as safe as Medtone. The delay triggered external and internal challenges such as stock price fluctuations, stockholder suits and layoffs. MannKind filed another FDA application in 2013 focusing on safety of the inhaler substitution. FDA delays caused the CEO to wonder about the success of his strategic framework. As the CEO awaited FDA approval in April 2014, he reflected on his dream to develop a product that tackled diabetes in spite of his frustration with the FDA process
- Identify the differences between external and internal analysis and determine which strategic approach would assist organizations to analyze the appropriateness of the firm’s decisions aimed at FDA product approval and marketplace success. (Cognitive Levels #1 and #4, Question #1)
- Assess the effectiveness of company product strategies in the pre-approval FDA stage to achieve company goals. (Cognitive Level #6, Question #2)
Evaluate the role financial analysis plays in the determination of a firm’s ability to achieve final FDA approval and firm sustainability. (Cognitive Level #6, Question #3)