If you haven't listened to Dr. Ekman's presentation at the Cowen conference, I strongly suggest that you take a listen. It's available through the Protox website.
High level of credibility. Some highlights from memory:
The current ongoing transrectal safety study will be available for presentation to the FDA later this year.
Protox expects to release the 12-month data from the Phase 2b study (Triumph) later this year as well. Recall that the 6 month study was released on 02-Jun-2010 (20 months ago).
These comments, coupled with the comment that the Phase 3 study will begin later this year suggests that the safety data and the 2b efficacy data supports the next phase and may be release coincident with the FDA submission for the SPA or upon receipt of the SPA.
Phase 3 will be a multi-center study (USA/Canada/Europe) with approximately 550 patient enrolled. Enrollment will take 9 months to complete.
3-month safety and efficacy is the traditional endpoint for NDA approval.
Lastly, Protox will change its name (inferred later this year) to avoid negative confusion with botox. The name will become Sufurus (??? on spelling). Dr. Ekman also indicated that the company will pursue a US exchange listing at the appropriate time.
Putting on my math hat, PRX302 should be cleared for market by early 2014, with several catalysts in between.