In order for a drug to have a chance of success, TWO separate and distinct approvals are needed. The first of course is approval by the FDA in this country or the appropriate regulatory body overseas.
But that isn't at all enough. What is ALSO needed is willingness of the insurance companies to reimburse the manufacturer.
In certain instances, insurers will indeed refuse to reimburse the manufacturer even when the drug has been duly approved. That actually happened to Pfizer in 2007 with its inhaled insulin product Exubera. Yes - Exubera was indded approved by the FDA but insurers wouldn't reimburse for it because they felt that there was no extra efficacy in inhaled insulin than injected insulin - the inhaled product simply cost more and no way were the insurers going to pay for that.
Refusal of the insurers to reimburse Pfizer for strictly a convenience product was the reason why PFE decided to take Exubera off the market in Q4-07. It's also the reason why diabetes-products leader NVO and other big pharma LLY discontinued tests on their own promising inhaled insulin products.
In the UK, the government there wouldn't reimburse for inhaled insulin unless a patient saw a psychiatrist and was classified as "extremely needle-phobic." How many folks would really want to go through THAT?
So be VERY careful with MNKD and Afreezza. Unless the insurers have a complete change of heart, the only folks that will buy the product will be those willing to pay the entire cost out of their pocket. And as you might imagine, the market for that is EXTREMELY small. So know the history of Exubera and why PFE removed the product in late 2007 even though it had been approved both here and abroad. PFE simply couldn't make any money on it once the insurers refused to reimburse and there was nothing in the world that Pfizer could do to force them to reimburse for a costlier product having no more efficacy than injected insulin. If insurers won't reimburse, the product fails.