hello gang
well this morning i recieved a email from james yue that the activ-l v/s prodisc fda study will begin in just a few months. to late for me as i have been fixed by dr. bertagnoli and have no regretshttp://adrsupport.org/groupee_common...icon_smile.gif no thought many would want to know its about to begin.
warm regards
chuck

Well, Amen. Was there an EXACT date in the letter?

Thanks.

they want fda paper work done on march 1st so i would think it would be starting near then.
chuck

should I assume we are still referring to the one level trial or is there any word regarding 2 levels?

doesn't say lbp basically say get all your testing done mri ct etc.. and march 1st or after go up there and fill out paper work.
chuck

I also have received a letter from Dr Yue. It says the FDA has approved 1 level. He will be using Prodisk to compare to Activ-L. Costs are pretty much covered by the study sponsor, but we may be required to cover surgeons fees of $3000-$5000. Beats $30000++...

Ann

see folks the timing is interesting...i thought the 2 level trials for prodisc started about 6 mos after the 1 levels trials. the FDA approved prodisc for 1 level end of august...6 mos later puts us at the end of Feb....so do these march trials sound encouraging to anyone else??? perhaps there's going to be some movement on FDA approval for 2 levels of prodisc????

wasn't Activ L orig going to be tested against prodisc...then switched to Charite and now back to prodisc...is this because they want to do a 2 level activ L trials too?????

just wondering..if anyone hears more about 2 level possibilities...please post http://adrsupport.org/groupee_common...icon_smile.gif

Dr Yue wanted to use Prodisk vs Activ-L all along but he got tired of waiting fir FDA to approve the pro disk so, end of last summer he submitted paperwork for Charite vs Activ-L. Since Prodisk has now been approved he must have submitted more paperwork to request using Prodisk. His letter did not indicate 2 levels so I don't know if that means he can only do 1 level for now or 1 level is what he is starting with. Sorry I don't know more, will certainly ask...

Ann