> does this basically mean that afrezza with the next gen inhaler

> can perform .4% worse than the insulin aspart and still receive

> non-inferiority from the fda?

First, the estimate on the difference in a1c reduction is estimated along with 95% confidence interval. e.g., difference = 0.1%, 95% CI = (-0.3%, 0.5%)

If the lower boundary of the 95% confidence interval is above the non-inferiority margin [delta] (-.4% in AFFINITY I study), non-inferiority can be claimed.

Hence, the difference should be reasonably close to zero or better for Afrezza in order to show non-inferiority. I don't think this is a high huddle to overcome considering better kinetics with Afrezza.

Oncostat