what's taking so long

[LBP]

Harrison,

Your post about WellDiscL is very very interesting, however....was anyone at this most recent spine conference discussing the hold up for FDA approval for 2 levels? And what about the delay for the Activ L trials?????? What was said if anything about these timelines? This is just absolutely ridiculous how long it is taking for 2 level Prodisc approval in the US!!!!! ARGH!!!!!!!!!!!!

And for anyone that doesn't know me...Germany is not an option for me ...believe me it is impossible unless someone offers me $ out of the kindness of their heart. I do not have borrowing capability, no savings, and no family resources to do this.

[Harrison]

LBP, I agree it is frustrating to see these things put on hold without any visibility. And these matters are generally not discussed at these events. Perhaps in the future, we can mobilize the patient community to advocate and present at the FDA conferences!!!

I did attend an Active-L session, and I learned about five different US trial centers that are open (info pending). I have a call into Aesculap on this issue.

[LBP]

Thanks for your reply Harrison. I am keeping my eye on the next "proposed" date (7/17/07)for the FDA ortho device advisory panel mtg to see what it's topic will be... see http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdv...0&lf=1&nocancelled=1

[LBP]

Well the 7/17/07 FDA mtg seems to be about the Bryan Cervical Disc premarket approval, nothing for lumbar/prodisc or activL

http://www.fda.gov/opacom/hpmeetings.html