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    Jim,

    This is pretty exciting, especially the letter.

    I know in the past you mentioned it would be available for compassionate use, do you know when that would fit into the timescales in the letter?

    thanks,

    Comment


      niallel,

      Compassionate use will be available after the trial subjects are operated on.

      Comment


        The trial subjects in the first US phase later this year?

        So there is a possibility that compassionate use will be available next year?

        Comment


          Yes, later this year or next.

          Comment


            Thanks Jim, thats great.

            Is there a plan for how it will be delivered?
            Do you have healthcare providers lined up? Or are you stepping back and letting healthcare providers decide to do this if they want?

            I think everyone is crying out for something to go and do, you can tell this from the amount of people who have gone to the Far East for non-proven treatments.

            Comment


              niallel,

              First step is to find a neurosurgeon.

              Not positive, but don't think insurance companies will come on board until the Phase III proves efficacy in a large # of subjects.

              Comment


                Thanks Jim, I think I'd raid my savings for it.

                Comment


                  Thanks Jim - Good read on that pdf file! exciting news...
                  any follow-up yet for the past volunteers who participated the passed trials? been quite a few years since the last trial ended...
                  "Talk without the support of action means nothing..."
                  ― DaShanne Stokes

                  ***Unite(D) to Fight Paralyses***

                  Comment


                    Originally posted by Jim View Post
                    We are on schedule to begin this year. There is a meeting in July for all involved in the trial.

                    FDA is the wild card but I don't expect any delays. Once approval is granted we will let you know how to apply.
                    What day is the meeting in july? With who, and for what?
                    "That's not smog! It's SMUG!! " - randy marsh, southpark

                    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


                    2010 SCINet Clinical Trial Support Squad Member
                    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

                    Comment


                      Originally posted by Jim View Post
                      We are on schedule to begin this year. There is a meeting in July for all involved in the trial.

                      FDA is the wild card but I don't expect any delays. Once approval is granted we will let you know how to apply.
                      Excited about 2020!!!!
                      I was injured 2 weeks after my 16th birthday on June 14th, 2004. My level of injury is C5 complete, but I can move my wrist.

                      My screen name comes from the movie The Eternal Sunshine of the Spotless Mind

                      Comment


                        Originally posted by Moe View Post
                        Thanks Jim - Good read on that pdf file! exciting news...
                        any follow-up yet for the past volunteers who participated the passed trials? been quite a few years since the last trial ended...
                        They plan to bring the subjects back for examination, not sure of the funding for, or timeline.

                        Originally posted by lunasicc42 View Post
                        What day is the meeting in july? With who, and for what?
                        In preparation for pending approval, the clinical trial core committee of physicians, surgeons, and rehabilitation experts will be held in late July. Items on the agenda include: update on the FDA Application IND, U.S. protocol, surgery, transplants, (validation), walking program, budget and funding, data collection, and schedule. This is a major step in bringing these trials to the United States.

                        Comment


                          Originally posted by Jim View Post
                          They plan to bring the subjects back for examination, not sure of the funding for, or timeline.



                          In preparation for pending approval, the clinical trial core committee of physicians, surgeons, and rehabilitation experts will be held in late July. Items on the agenda include: update on the FDA Application IND, U.S. protocol, surgery, transplants, (validation), walking program, budget and funding, data collection, and schedule. This is a major step in bringing these trials to the United States.
                          Nice...it's mid-july now
                          "That's not smog! It's SMUG!! " - randy marsh, southpark

                          "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


                          2010 SCINet Clinical Trial Support Squad Member
                          Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

                          Comment


                            Originally posted by Jim View Post
                            They plan to bring the subjects back for examination, not sure of the funding for, or timeline.



                            In preparation for pending approval, the clinical trial core committee of physicians, surgeons, and rehabilitation experts will be held in late July. Items on the agenda include: update on the FDA Application IND, U.S. protocol, surgery, transplants, (validation), walking program, budget and funding, data collection, and schedule. This is a major step in bringing these trials to the United States.
                            Sounds promising, will have my fingers crossed as same as last 6 years... My little cousin is going to be a neurosurgeon spine Dr. She said these trails can take 10 years..let's hope. My legs are sime size as day i was hurt so i think my chances are pretty good "if" something ever truly happens and is available to public

                            Comment


                              Originally posted by Jim View Post
                              They plan to bring the subjects back for examination, not sure of the funding for, or timeline.
                              I can't understand why the follow-up routine stopped, especially for those that gained recovery... doesn't it make sense the importance to keep in touch with them to be aware of further gains and/or safety issues??
                              Last edited by Moe; 15 Jul 2017, 7:05 PM.
                              "Talk without the support of action means nothing..."
                              ― DaShanne Stokes

                              ***Unite(D) to Fight Paralyses***

                              Comment


                                So this may be a dumb question but is this strictly for paras?

                                Comment

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