Even if they gain approval, it won't mean much as most insurers WILL NOT REIMBURSE. The precedent was set when insurers wouldn't reimburse for Pfizer's approved product on the grounds that it was strictly a convenience product and they weren't going to pay two or three times the rate for injected insulin for a product that had absolutely no added efficacy.
On the other side of the pond, the U.K. government insurance plan wouldn't reimburse unless a patient first saw a psychiatrist and was duly certified to be "extremely needle phobic." How many people are about to do that?
With such a potential tiny market, no big pharma is going to partner with MNKD because the profits just aren't there. And MNKD MUST have a partner since ii simply doesn't have the needed sales force or infrastructure. This stock is strictly one to stay away from unless you enjoy losing your money.