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Thread: ChinaSCINet Update

  1. #2731
    Senior Member lunasicc42's Avatar
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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!!!! "


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  2. #2732
    That applies to the upcoming Phase IIb trial.

  3. #2733
    Senior Member lunasicc42's Avatar
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    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

  4. #2734
    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.

  5. #2735
    Quote 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---->

  6. #2736
    Quote 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 $ ?

  7. #2737
    Quote Originally Posted by ineedmyelin View Post
    Everyone gets detethering if needed, right.
    Correct


    Quote 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.

  8. #2738
    Senior Member Moe's Avatar
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    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?
    "I'm Moe, and I approve this message..."

  9. #2739
    Moe, I'm not eligible to be in the trial, completes only.

  10. #2740
    You mentioned LMN trials coming. Is that animal or in humans?

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