Unlike PFEs failed product, Afrezza is a better,fast acting bolus insulin that is in the blood in @15 minutes and leaves a few hours later. No hypoglycemic issues.
Exubera was a me too drug with a Bong like dispenser and no clear medical advantage which is why it wouldn't get the insurance reimbursements. Afrezza, per the FDA request, is also being tested for type 2 which means it could be the super blockbuster drug for the next dozen or more years.
Other than convenience, no inhaled insulin product has an efficacy qdvantage over injuected insulin and that is why insurers won't reimburse for it. Fai9lure to reimburse has nothing whatsoever to do whether the device is bong-like or fashionable. NVO and LLY clearly saw the handwriting on the wall and scrapped their own promising inhaled insulin stage 3 products within weeks of Pfizer taking Exubera off the market in October 2007.
Due to reimbursement problems here and abroad, there would be such a small effective market for Afrreeza even if approved that no big pharma would be even remotely interested in a partnmership. And MNKD simply doesn't have the ssales structure to go it on its own; they MUST have a partnership.
Unless the insurers completely reverse themselves which they are most-unlikely to do, MNKD is a doomed company.
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.