And the decision is ……

And the decision is ……

According to a press release issued by MannKind (NASDAQ:MNKD) the FDA has issued yet another complete response letter in regards to their inhaled insulin Afrezza®. According to the release; “The principal issue raised by the FDA concerned the usage of in vitro performance data and clinical pharmacology data to bridge MannKind’s next-generation inhaler to the phase 3 trials conducted using its MedTone® inhaler. The FDA has requested that MannKind 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 complete response letter, the FDA stated that after an adequate titration of study medication there should be at least twelve weeks of relatively stable insulin dosing at the end of the treatment period.

The FDA has also requested additional information concerning the performance characteristics, usage, handling, shipment and storage of the next-generation device, 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.”

The release goes on to say: “As we reported last fall, we have already begun a series of studies of the next-generation device in patients with type 1 (Affinity 1) and type 2 (Affinity 2) diabetes,” said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. “Consistent with the direction we received in the complete response letter, these trials are designed to focus on careful titration of insulin dose and include at least twelve weeks of stable dosing. We plan 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.”

Mr. Mann continued, “While we are disappointed with the complete response letter, we are encouraged that the FDA is asking for clinical studies only to confirm the bridging and handling of the next-generation device in order to compare it to the device used in our extensive clinical program. We remain committed to working with the FDA to make AFREZZA available to people with diabetes.”

The company has scheduled a conference call at 4pm EST to discuss this latest development and it will be interesting to see how they try and spin what clearly is not good news. Diabetic Investor will have a complete wrap when the conference call ends. Stay tuned, this could be fun.