Hi U / Lia,
This was a great concern of mine as well, as the bridging of the two inhalers is what sank the last NDA.
From what I have gathered, thanks to Brentie, is that there are two components from the Affinity 1 study that will bridge the two devices:
1. Pulmonary safety comparisons, as tested by simple spirometry, rather than PFT
2. A1C reduction vs. Lantus arm
- Both the medtone and the dreamboat arm must show HBA1c inferiority to the Lantus / Humalog arm.
Source:
http://seekingalpha.com/article/305499-mannkind-s-ceo-discusses-q3-2011-results-earnings-call-transcript?part=single
