I don't know if you are aware they have a positive Phase 3 study already. I don't think they would get combo use in their label obviously and I don't see great commercial prospects as montherapy with their (inferior) efficacy and (likely) much higher cost. So basically they have one positive study which is highly significant (though I believe slightly above .01) using the same drug that is already approved in 3 other forms (IV, Sub-q and inhaled) and two additional trials that while not significant trend and provide safety data. In orphan indications with one positive trial and < .01 significance there are numerous precedence for approval. So I wouldn't rule out an approval at all.
I wouldn't sell at these prices but I would only cosider buying again somewhere below 30 myself (though it may never get there).
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