Longs have a huge ace in the hole which is rarely discussed on this board. Namely, around 90% of the world's 250,000,000 or so diabetics live outside of the USA (and therefore the FDA's jurisdiction).
China and other Asian countries in particular have a lot of interest in Afrezza. In fact, if memory serves, China tried to arrange a meeting with Al Mann last year. And that was before dreamboat.
IMHO, these 225,000,000 diabetics alone should justify at least $15/share today.
Yes, this is an important point often overlooked. Last year, the potential BP partner and MNKD agreed on a $2B valuation for annual AFREZZA sales in NORTH AMERICA. That would equate to about $8B a year when you add EMEA and APAC.
FDA takes a very dim view of pulling an end run. If you ever want the U.S. market, you wait for FDA approval and not jump-start Afrezza by going to China. MNKD is so close to FDA approval, it would make no sense for MNKD to thumb its nose at FDA.
But you raise a valid point about the size of the market for ROW (rest of world). There is nothing holding Mann back from signing a ROW partner, unless nobody is interested until FDA approval. The ROW partner is never priced into the pps until one is signed up. Dendreon still doesn't have a ROW partner, and its prostate-cancer treatment Provenge is about 99-percent assured of FDA approval within the month.
In fact, here's how Yahoo's Business Summary for MNKD begins:
"MannKind Corporation, a biopharmaceutical company, focuses on the discovery, development, and commercialization of therapeutic products for diseases, such as diabetes and cancer. Its lead product candidate, AFRESA, a rapid-acting insulin that has completed phase 3 clinical trials for the treatment of diabetes in the United States, Europe, and Japan."
Note the last 3 words.