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    is it correct that if the fda gives approval for a phase 3 trial, one can undergo the treatment for pay without having to wait for the phase 3 trial to conclude? Do I have that right?
    "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

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      That applies to the upcoming Phase IIb trial.

      Comment


        how long is the phase IIb trial going to be and whats going to be the difference between the phase IIb trial and the phase 3 trial? I am trying to figure out everything and which one would be better for me to partake in regarding time and the level of efficacy ...
        "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

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          The IIb trial in the US will consist of 24 subjects. Eight- cells + walking, eight- cells + 6 weeks of oral lithium + walking, eight- walking only. This will also be done in India and Taiwan. Not sure of the number of subjects in those but I don't think they will do walking only group, and possibly incompletes. The FDA required us to have a walking only group. After the patients in the US are operated on it will be available in the US for expanded compassionate use. The Phase III will be in a large # of subjects of the best group.

          Comment


            Originally posted by Jim View Post
            The IIb trial in the US will consist of 24 subjects. Eight- cells + walking, eight- cells + 6 weeks of oral lithium + walking, eight- walking only. This will also be done in India and Taiwan. Not sure of the number of subjects in those but I don't think they will do walking only group, and possibly incompletes. The FDA required us to have a walking only group. After the patients in the US are operated on it will be available in the US for expanded compassionate use. The Phase III will be in a large # of subjects of the best group.
            Everyone gets detethering if needed, right.
            "I'm manic as hell-
            But I'm goin' strong-
            Left my meds on the sink again-
            My head will be racing by lunchtime"

            <----Scott Weiland---->

            Comment


              Originally posted by Jim View Post
              The IIb trial in the US will consist of 24 subjects. Eight- cells + walking, eight- cells + 6 weeks of oral lithium + walking, eight- walking only. This will also be done in India and Taiwan. Not sure of the number of subjects in those but I don't think they will do walking only group, and possibly incompletes. The FDA required us to have a walking only group. After the patients in the US are operated on it will be available in the US for expanded compassionate use. The Phase III will be in a large # of subjects of the best group.
              How do I become one of the 24 ??? That's the million $ ?

              Comment


                Originally posted by ineedmyelin View Post
                Everyone gets detethering if needed, right.
                Correct


                Originally posted by Ajstevens View Post
                How do I become one of the 24 ??? That's the million $ ?
                You are on the eBulletin list, all trial info is shared that way.

                Comment


                  Jim, since the US trial will be performed in your home state... I understand that this may be a secretive or personal question, but as a fellow incomplete quad living in Jersey and from the "inside"... are you participating in this IIb trial?
                  "Talk without the support of action means nothing..."
                  ― DaShanne Stokes

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

                  Comment


                    Moe, I'm not eligible to be in the trial, completes only.

                    Comment


                      You mentioned LMN trials coming. Is that animal or in humans?

                      Comment


                        LNM is still in animals.

                        Comment


                          Jim LMN trial expected next year?
                          How are animal results going on? Is it possible to reverse LMN deficits?

                          Comment


                            Originally posted by lunasicc42 View Post
                            I am trying to figure out everything and which one would be better for me to partake in regarding time and the level of efficacy ...
                            This is where I am too. Based on the info provided in this thread I'm planning on heading east mid-winter to mid-spring. I'll go under compassionate use if I have to, I just need to get started. I have no desire, nor the will, to wait until 2020.

                            Comment


                              Originally posted by tumbleweeds View Post
                              This is where I am too. Based on the info provided in this thread I'm planning on heading east mid-winter to mid-spring. I'll go under compassionate use if I have to, I just need to get started. I have no desire, nor the will, to wait until 2020.
                              Yes I don't want to wait a minute more than I have to once satisfactory efficacy is proven
                              "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

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                                For sexual function to return is it required to regularly "exercise" your junk? Hehe
                                Last edited by lunasicc42; 17 Aug 2017, 8:18 PM.
                                "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

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