I am finishing listening to their Q3 call now. I have not followed the company closely but found a couple things interesting.
. In the remarks before Q&A (after the opening and financials) a member a management spent a good 5 minutes talking about why their product is NOT exubera. Which I would have thought nothing of if this were say 2 years ago after Pfizer gave up on it. It was amusing to hear them say everyone understands this except wall st. . . They said even if they do get approved this year they wouldn't be in a position to sell it till 2H '11. . They have to do some sort of EKG study for the MAA.
I don't follow the company at all but these three things led me to speculate that another CRL may be more likely then a straight approval. While I realize they have potentially a huge market opportunity I can't seem to reconcile that with their current market cap (they have a fair amount of debt!). They mentioned a phase 2 study in melanoma but I think that is all they have. So despite managements contention otherwise I think wall street is valuing them like they have some chance at success.