Auxilium , the maker of the collagenase (Xiaflex), is probably going to be doing a follow up research study to better understand the nature of Dupuytren's disease and the rate of recurrence in joints treated with Xiaflex. The study consists of 1 visit per year for the next 4 years . They will be taking finger measurements of both hands and monitoring blood for antibodies to the collagenase.

Wonder what this means in regard to FDA approval?

Aussie, do you know if that surgeon was speaking from first hand experience in the Xiaflex trials? If so, those statements are discouraging. However it seems many surgeons are anxious to discount Xiaflex and NA without actually knowing much about them.

I had surgery at 48 - about three years ago, it came back, and I did the Xiaflex clinical trial with better results - so far. I'm signed up for the follow-up study and get my first measurements Tuesday January 5, 2010. I need one more good injection and snap on my left little finger once FDA approves (in 3 or 4 months I hope) - but I expect I'll have recurring problems forever. Better this than a lot of other diseases.

Wonder what this means, especially now that we are reading about more long-term follow up with Auxillium and Xiaflex

http://www.evaluatepharma.com/Universal/...isEPVantage=yes

"However, while some analysts are bullish about the drug's chances of shifting its approval hearing from December to August, there are others who believe that ****niggling concerns over hypersensitivity, which have started to envelop the injection, ****could mean the US regulator will take both a more cautious stance and its time in deciding to grant approval.

"hypersensitivity, which have started to envelop the injection"-- can someone translate that into English for me?

Good question Kelley.