I really wonder why they will not submit an NDA for the Type 1 trial first and by itself. There seem to be several good reasons to take this approach.

1) This is the trial that is head to head with the Medtone inhaler and answers the specific reason for the previous CRL.

2) The trial was started first, had less problems with enrollment, and will have complete data well ahead of the Type 2 study. (correct?)

3)This is the study that is not double blind.

4) A simple submission for Type 1 only showing the requested equivalance of the new device is the most simple and straightforward and leaves the least room for bollixing by the FDA.

5) Production capacity is limited as Afrezza is launched so the revenue stream is little effected.

6)Any approval gets MNKD closer to partnership and financial stability.

As we say in Vermont, "Let's get 'er done."