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genisi

10/10/11 3:21 AM

#128123 RE: ghmm #128031

BSTC / AUXL / Xiaflex

On the safety concerns with Collagenase - ruptures being the most scary, as nicely put by rkrw #msg-65958671 :-) It would of course depend on incidence plus consider that surgical treatment also comes with its own risks.
There's no FDA approved drug for Peyronie's but I've found this review: http://www.nature.com/ijir/journal/v14/n5/full/3900917a.html that makes me wonder if Xiaflex' risk/reward/price profile can be better than verapimil's. Also, I'm quite sure Collagenase has no COM patents and the IP protection beyond orphan exclusivity period might not be very strong, but I haven't looked into this.

Phase III trial is allowing Modeling and a fourth treatment

Agree that phase III is better designed than phase II (so have a better chance to hit) with also longer follow-up (should help showing effect in responders) and enrollment of patients who have symptoms for at least 12 months ('fresh' patients sometimes have remissions).