As one who has followed this stock since meeting Dr. Averback in 2005, it has always been hard to understand why the development takes so darned long.
The recordati license peaked my renewed interest, as did my own advancing BPH symptoms. As I looked into it, it becomes clear that it's not at all easy to qualify for the trial. During the one year duration of the trial, and a few months prior, a patient cannot take any other medications of any kind for BPH. Many existing BPH patients are on flomax or some other treatment, and are loathe to drop them, if their symptoms are severe enough.
Your prostate has to be larger than normal, but not TOO big. This, plus the fact that urologists have a disincentive to publicize or actively encourage patients to consider it, makes it a long tough slog to enroll enough patients.
There is at least one year remaining if not more in the trials, then analysis and filing. I'm sure it's possible that a pharma might jump in with a huge license deal in order to block others from this market, but it's not because the trial is nearly finished.