- A Final Assessment of MannKind Stock
- Jan 20 2011
Contrary to a lot of headlines, MannKind’s application to market its inhaled insulin product AFREZZA was not rejected by the Food and Drug Administration. Instead, the regulators issued another “Complete Response Letter,” requesting information that essentially bridges the company’s next-generation “Dreamboat” inhaler to data derived from the Phase III trials that were conducted using its first-generation MedTone inhaler. The FDA has asked MannKind to conduct two clinical trials with the next-generation inhaler (one in patients with type 1 diabetes and one in patients with type 2 diabetes), with at least one trial including a treatment group using the MedTone inhaler in order to obtain a head-to-head comparison of the data for the two devices. In the CRL, the FDA stated that after an adequate titration of study medication there should be at least 12 weeks of relatively stable insulin dosing at the end of the treatment period. It also requested additional data concerning the performance characteristics, usage, handling, shipment and storage of Dreamboat, an update of safety information related to AFREZZA as well as information on proposed user training and changes to the proposed labeling of the device, blister pack, foil wrap and cartons.
According to Alfred Mann, the company's founder and chief executive, a series of studies of the next-generation device in patients with type 1 and type 2 diabetes is already underway, "consistent with the direction we received in the complete response letter." As well, the company plans to "meet with the agency as quickly as possible in order to be confident that these trials, with appropriate modifications to incorporate a comparison to the MedTone device, will suffice in addressing the agency's questions about patient use and robustness of the next-generation device."
The timeline to another FDA decision is difficult to determine at this juncture, factoring in the time needed to conduct the requested studies, compile the data, prepare a response to the CRL, and have regulators review the application again. That said, the FDA’s response strongly suggests that the science behind AFREZZA is not an issue and the product will ultimately be approved. Significantly, too, despite the recent setback, the product’s long-term potential remains substantial. MannKind will most likely have to raise additional money to continue its R&D program. The delay gives the company additional time to secure a marketing partner, one which may be encouraged by the specifics of the FDA’s Complete Response Letter. All things considered, MannKind shares now represent an interesting long-term investment alternative, as opposed to the interesting “special situation” that it was when we brought it to subscribers’ attention almost exactly a month ago.