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Almost one year after the unanimous recommendation for approval by the FDa Advisory Committee (I was non-voting patient representative), DBS is NOT yet approved by FDA. It is only available under experimental protocols. While neither the sponsor nor the FDA have made public what the concerns have been, both have reported that they are working very hard to resolve the issues. I believe that some missing data and other additional information requested at the hearing has been at least part of the problem. I have received calls from people looking for information on where they can get the procedure done, how much it costs, whether Medicare or insurance pay, etc. Does anyone have this information? With problems like this in mind, The Parkinson's Disease Foundation began organizing the "Parkinson's - FDA - Industry Initiative" early this year to work with Sponsors and the Government to provide patient input to design of clinical trials and to the determination of risk-benefit tradeoffs for "timely" approval of safe and effective new PD treatments. In our early stages of development we have not worked with Medtronic to date. For more information see www.parkinsonscare.org/RxDEV.html Perry Cohen Washington DC ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn