Here's a study, the trial MKC-TI-117 results, showing p values are on page 58.
http://www.ucdenver.edu/academics/colleges/medicalschool/centers/BarbaraDavis/OnlineBooks/Documents/Keystone2011/Keystone%202011%20Bode%20Ultra%20Fast%20Acting.pdf
There was an issue in the last trials getting the trial doctors to adjust the basal insulins to a low enough level. That problem was addressed by the FDA, and it is a requirement this go round. That should help show even better A1c improvements.
The problem last time was the lack of trials using the dreamboat inhaler when the actual trials were done using the Medtone inhaler. The FDA seemed content with accepting an equivilance study, but right before they were scheduled for approval it was pointed out this violated FDA rules, & studies using the dreamboat would be required. It is interesting that this was brought to the FDA's attention by a hedge fund manager who was short the stock.
Hopefully there will be no surprises this time!
