Wont happen. This trial and all outcomes was designed by the FDA. FDA even asked for the type 2 study to approve it for the wider population. Per Al Mann the FDA mentioned it first. Good thing!

I have actually never seen a company get a crl a 3rd time around. If anyone knows of one please let me know.

There has been 2 inhaled drugs approved in the last 6 months. One of them even had safety issues. MNKD will be approved!