Adam didn't say it would get approved,he said it would probably have positive trial results.That's not really new,remember this?
MannKind expects to announce top-line results from the Afrezza phase III trials -- one each in type 1 and type 2 diabetics -- in the middle of August. If the studies are positive, the company says it can resubmit Afrezza to the FDA sometime in September or October. Assuming a six-month review, an FDA approval decision could occur in March or April 2014.
Frankly, I don't care if the Afrezza studies are positive or not. I'm more than happy to assume positive data. Even so, I'd say the odds of an FDA approval are a toss up, at best. Predicting FDA reviews of diabetes products today is a fool's errand. Seemingly out of nowhere, FDA rejected a long-acting insulin from Novo Nordisk (NOVO) in February, yet in March, the agency approved the first SGLT2 inhibitor, Invokana, from Johnson & Johnson (JNJ_). [FDA rejected a similar SGLT2 inhibitor from Bristol-Myers Squibb (BMY_) and AstraZeneca (ZAN) last year.]
For the sake of argument, let's be super optimistic and assume FDA approves Afrezza, allowing MannKind to introduce the second inhaled insulin device into the diabetes market. What happens next will not be pretty for MannKind or any investor silly enough to own the stock.
The fact is that Afrezza trips all the FDA red flags -- a new, unproven medical device, a diabetes drug that is inhaled into the lungs, two previous rejections, and a history of discord between MannKind and regulators. Good luck Al Mann-iacs because you'll need it.
I'll now hand over the Mailbag to David Kliff, a diabetes expert who runs the well-respected and widely followed Diabetic Investor newsletter, to explain:Blah,blah blah,blah blah,blah,blah.
http://www.thestreet.com/story/11888089/1/biotech-stock-mailbag-mannkind-ariad-oncolytics-biotech.html
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Now that we are about to get positive trial results,it's time for him to focus on the next possible thing that could go wrong...(from his new article)
"MannKind is also the seventh-most shorted stock in the bio-pharma sector, with just under 29 percent of shares sold short as a percentage of the float. The MannKind short thesis is less about the risk of failed clinical trials and more focused on significant doubts about the company's ability to 1) get Afrezza approved; 2) find a marketing partner; and 3) generate meaningful revenue.
