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Re: ghmm post# 128031

Monday, 10/10/2011 3:21:16 AM

Monday, October 10, 2011 3:21:16 AM

Post# of 252252
BSTC / AUXL / Xiaflex

On the safety concerns with Collagenase - ruptures being the most scary, as nicely put by rkrw #msg-65958671 smile 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).

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