OPC,

Bioavailability is part of the Type 1 trial...

Hakan:

"The Type 1 trial has 3 arms, each scheduled to finish with 133 patients. 2 arms will deliver AFREZZA: 1 with the Dreamboat device, the other with the MedTone inhaler, as a bridge to our earlier trials. The third arm will use a rapid-acting analog and conventional injection therapy. All 3 cohorts will use Lancet as the basal insulin."

And it appears that non inferiority is all that is needed for the FDA...

Al:

"In the Affinity trial, the FDA has authorized us to engage an independent monitor who will review e-diary records and will contact the clinicians responsible for patients that are not complying with the protocol. This should not only assure reaching a non-inferiority requirements for approval, but hopefully, it may even enable us to show superiority of AFREZZA in HbA1c. "