When speaking about the MKC-171 trials during the Q3 conference call, Al Mann mentions a second endpoint defined as superiority.

http://seekingalpha.com/article/971551-mannkind-management-discusses-q3-2012-results-earnings-call-transcript?part=single

He then states:

"The protocol calls for titrating the basal insulin to lower fasting glucose to under 120 milligrams per deciliter. Although the -- in the event of a hypoglycemic event, titration is to be terminated.

Patients on AFREZZA, who are compliant in meeting the fasting glucose target should reach near-normal A1Cs, whereas almost all patients are rapid-acting analogs for those fasting glucose likely could not be safely lower that significantly.

Our problem in early trials is that our fear for hypos, it has been difficult to get fasting glucose levels much reduced. The most significant cause of hypos with insulin therapies today is the late postprandial hyperinsulinemia seen with current prandial products. That excessive insulin causes a postprandial plunge of glucose below baseline that offsets the higher prandial rise, producing a minimal average change from baseline. A1C, which effectively reflects the average glucose level over 2 to 3 months is largely determined for this deficient insulin by that high fasting level. AFREZZA lowered primarily [indiscernible], but does not exhibit the late hyperinsulinemia that causes hypoglycemic risk. Yet even so because of the fear of hypos is so great -- because it's so great, the basal insulins have not been increased in our earlier studies even for AFREZZA patients. For example, in our earlier MKC-117 trial, fasting glucose was supposed to be adjusted to under 120 milligrams per deciliter. However, even though required in the protocol, average basal insulins in that study were not increased. And as a result, the fasting glucose remained too high, masking the advantages of AFREZZA. The average A1C reduction in the 117 trial for AFREZZA cohort was actually slightly better than for the insulin aspart that is NovoLog, but not enough to show superiority.

What is truly different in 171 is the FDA understands this and has authorized us to retain an independent monitor who sees the e-Diary data, and who is charged to contact the clinician with any noncompliance. With this tool, there's a much greater likelihood that fasting glucose for those on AFREZZA will be lowered below the target of 120 milligrams per deciliter. The only non-inferiority in this trial is required for FDA approvals, with such compliance, AFREZZA patients should perform exceptionally well in this study, reaching significantly lower A1Cs. Such improvement would be unlikely for patients on rapid-acting analogs.

Let me provide an example to illustrate the significance of what this compliance and the 171 study should make possible. With basal insulin titrated for an AFREZZA patient, to yield an average fasting level of, say, 110 milligrams per deciliter and with prandial glucose likely rising an average of, say, about 40 milligrams per deciliter over 2 hours for each meal, the result in A1C at 3 months would be about 5.8%, essentially normal for a nondiabetic. That would really be outstanding. For those using current prandial insulins lowering fasting glucose significantly would not be safe, and the A1Cs would, thus, not be substantially reduced."

So, my take on this is, if the independent monitor is able to ensure compliance with meeting the fasting glucose target levels of less than 120 mg per dl and hence much improved HbA1Cs, it could create a catalyst for the stock during the summer of 2013.What do you think?