Bob,

The Affinity 2 trial is a superiority trial using patients poorly controlled on metformin and insulin naive. It keeps patients on their existing meds and adds either Technosphere/insulin or Technosphere placebo. So any effects seen will be attributable to Afrezza.

Assuming they do show superiority (they sound really confident), this would put Afrezza out there to be used early in the course of diabetes.

Now I may be wrong, but I would think it is the medical organizations (such as ADA) that put out guidelines as to preferred sequencing of treatment. I don't think any further studies will be needed in this regard - but I could be wrong.