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Thread: Seems like nothings happening....

  1. #81
    Senior Member lynnifer's Avatar
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    Oh gawd I have a decade on you .... right now my dad is exactly twice my age - he is 88
    Make America Sane Again. lol

    T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

  2. #82
    Newly injured... but have very little hope in much happening outside of stimulators and exos in my lifetime. Rebuilding the CNS seems very far from our reach, and understandably so. Appreciate and admire the labor and research invested in any progress, however it is such a deep and extrememly complex system to reconstruct. Technology has advanced, but rebuilding central nerves? I'm guessing it's still the 80s in that dept

  3. #83
    Quote Originally Posted by Jim View Post
    This will allow anyone to receive this treatment at cost right after we recruit and randomize the subjects for the Phase IIb, later this year.
    Jim, it sounds like you're quite confident that this treatment will be available, even to patients outside of the trial, this year, at least in the U.S.A. (barring any big unforeseen delays). And the trial only needs to start, not finish, for it to be available to us? So, 2017 is finally going to be the year? The way I read it, it seems clear that that's what you're saying but I just want to confirm that, as it's much too important to make assumptions. There have just been too many disappointments in the past decades, my enthusiasm must be guarded.

    Also, is India still ahead of the US in Phase IIb? I think I read where they would start this spring. Have they started recruiting and will their trial results be accepted by the FDA as a greater pool of resource for phase III? Or will those results not be needed or accepted here.

    Thanks Jim


  4. #84
    Senior Member Tbone57's Avatar
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    Quote Originally Posted by Denied2016 View Post
    Newly injured... but have very little hope in much happening outside of stimulators and exos in my lifetime. Rebuilding the CNS seems very far from our reach, and understandably so. Appreciate and admire the labor and research invested in any progress, however it is such a deep and extrememly complex system to reconstruct. Technology has advanced, but rebuilding central nerves? I'm guessing it's still the 80s in that dept
    If your're interested in whats going on and so on, there are two women who will be going around the country making a film on current research and technology one is in a wheelchair with a c6 injury. You can follow them on Instagram and Facebook the name to look for is "thecuremap". Ones name is Kelsey who is paralyzed the other is Maddy her friend. Good luck, take it a day at a time and dont assume things are decades away or that something is going to get you out of prison tomorrow. Try to stay hopeful, find the middle ground.

  5. #85
    Quote Originally Posted by tumbleweeds View Post
    Jim, it sounds like you're quite confident that this treatment will be available, even to patients outside of the trial, this year, at least in the U.S.A. (barring any big unforeseen delays). And the trial only needs to start, not finish, for it to be available to us? So, 2017 is finally going to be the year? The way I read it, it seems clear that that's what you're saying but I just want to confirm that, as it's much too important to make assumptions. There have just been too many disappointments in the past decades, my enthusiasm must be guarded.

    Also, is India still ahead of the US in Phase IIb? I think I read where they would start this spring. Have they started recruiting and will their trial results be accepted by the FDA as a greater pool of resource for phase III? Or will those results not be needed or accepted here.

    Thanks Jim
    Tumbleweeds, the FDA IND process is very straightforward. Wise & team met with them for a Pre-IND meeting in Jan of '16. They told us what they wanted, followed by a negotiation, and an agreement. We then submitted a protocol for the safety studies agreed to. It was several months before they got back to us with the ok to start the study. I believe we started in July. These are long term studies which are nearly complete. We will soon submit the results and wait to hear back from the FDA. It is my understanding that we can not do anything to plan for the trial, until it is approved by the FDA.

    India and Taiwan are both ahead of us, should start in a few months. All the results combined, if positive, will make a strong case to go ahead with a phase III.

  6. #86
    Senior Member lunasicc42's Avatar
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    looking ahead ...any future thoughts of combining this treatment and epi-stim together ?
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  7. #87
    FDA seriously pisses me off!!! They take a long time to approve stuff. It seriously needs to be reformed. I can't believe other countries are way ahead of us in the Stem Cell field.

  8. #88
    Wait now its "if positive?" Im so confused n done with optimism

  9. #89
    Senior Member Moe's Avatar
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    Quote Originally Posted by Han Solo View Post
    Wait now its "if positive?" Im so confused n done with optimism

    I think he meant that if all 3 countries provide the same pattern or data that China had back in phase 2, then it would be suggested positive and strong enough to prove the FDA... Just like a lawyer to win in court, he/she must build a strong case to win by collecting solid evidence and everything else to win he case... makes sense.

    I met Jim 2 years ago in one of the open houses, I must say that as a fellow quad as I, it was obvious that he and his loving family dream for this to go through asap too as he's not having any special treatment from the 'inside' neither... I speek for myself but I'm sure that he too feels the frustration that things are not going fast enough... Hard working and active guy, that I can say!
    "I'm Moe, and I approve this message..."

  10. #90
    Quote Originally Posted by Moe View Post
    I think he meant that if all 3 countries provide the same pattern or data that China had back in phase 2, then it would be suggested positive and strong enough to prove the FDA... Just like a lawyer to win in court, he/she must build a strong case to win by collecting solid evidence and everything else to win he case... makes sense.

    I met Jim 2 years ago in one of the open houses, I must say that as a fellow quad as I, it was obvious that he and his loving family dream for this to go through asap too as he's not having any special treatment from the 'inside' neither... I speak for myself but I'm sure that he too feels the frustration that things are not going fast enough... Hard working and active guy, that I can say!
    Exactly, if these trials don't again produce positive results, there would be no point in taking it to phase III.

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