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Thread: InVivo Therapeutics Submits Updated IDE to FDA to Begin Spinal Cord Injury Human Stud

  1. #1

    Smile InVivo Therapeutics Submits Updated IDE to FDA to Begin Spinal Cord Injury Human Stud

    That's will be great to try it on people soon.



    InVivo Therapeutics Submits Updated IDE to FDA to Begin Spinal Cord Injury Human Study

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    Submitted by admin on 2/28/2013 @ 3:00 AM


    CAMBRIDGE, Mass. -- (BUSINESS WIRE) -- InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today announced the Company has submitted an updated Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) requesting permission to begin human studies in order to test its biopolymer scaffolding for the treatment of acute SCI.

    The updated IDE submission is in response to exchanges since InVivo’s April 12, 2012 meeting with the FDA. The filing contains additional information regarding the manufacturing and pre-clinical testing of the scaffolding device. Once approved, the IDE will allow InVivo to conduct an open-label human study to collect safety and efficacy data to support FDA approval of the first in-cord treatment for SCI. The Company is also working with the FDA in order to have the scaffolding device designated as a Humanitarian Use Device (HUD), a designation that InVivo expects will create a faster path to market.

    read...

    http://www.freshnews.com/news/766823...-begin-spinal-

  2. #2
    Junior Member Firefly_Aviator's Avatar
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    I've been following this company for almost 2 years and I'm pretty excited about their technology. Not sure why it's not posted about here more.
    L-1 Burst fx 8.11.2010
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  3. #3
    Quote Originally Posted by Firefly_Aviator View Post
    I've been following this company for almost 2 years and I'm pretty excited about their technology. Not sure why it's not posted about here more.
    Because people are petty assholes and don't like Inivivo's
    CEO, Frank Reynolds.

  4. #4
    Quote Originally Posted by Buck503 View Post
    Because people are petty assholes and don't like Inivivo's
    CEO, Frank Reynolds.
    ..or they are not all naive as a 5 years old child.

    It may help to use a due-diligence philosophy like "inch wide and mile deep."

    Paolo

  5. #5
    Quote Originally Posted by paolocipolla View Post
    ..or they are not all naive as a 5 years old child.

    It may help to use a due-diligence philosophy like "inch wide and mile deep."

    Paolo
    Paolo, I find I like many, believe some of their work has a shot. Some of their work I do not believe in. There are others I dislike personally but still believe their work has a chance. Then there are the ones I dislike personally and remain a total skeptic about their work.

    I believe everybody is entitled to all those opinions. As of today I haven't seen one ready to "GO". That may make a few mad because I don't like who they like. I can only hope they engage at an adult level. I am far too old to let the name calling stop my posting of opinions and am certain you (while not as old) feel the same.
    Last edited by c473s; 05-04-2013 at 06:51 PM.

  6. #6
    Quote Originally Posted by c473s View Post
    Paolo, I find I like many, believe some of their work has a shot. Some of their work I do not believe in. There are others I dislike personally but still believe their work has a chance. Then there are the ones I dislike personally and remain a total skeptic about their work.
    I know about the distrust here towards Frank as person but not towards the actual research. Could you please elaborate your scepticism, and which of their work do you believe in? Just interested in hearing points raised not concerning the person.
    Debating on CareCure is like participating in the special-olympics. You may win, but you're still disabled.

  7. #7
    Quote Originally Posted by c473s View Post
    Paolo, I find I like many, believe some of their work has a shot. Some of their work I do not believe in. There are others I dislike personally but still believe their work has a chance. Then there are the ones I dislike personally and remain a total skeptic about their work.

    I believe everybody is entitled to all those opinions. As of today I haven't seen one ready to "GO". That may make a few mad because I don't like who they like. I can only hope they engage at an adult level. I am far too old to let the name calling stop my posting of opinions and am certain you (while not as old) feel the same.
    c473, you are for sure much wiser than me.
    I am very radical (sometimes). I do that as there are enough people who nicely follow the mainstream and that's not good to stay connected with reality.

    My prediction is that INVIVO may get this neuroprotective "product" for SCI on the market and then they will move on more prifitable markets than SCI, just like ACORDA or Geron did. (Same will do the company who has bought stem cell technology from Geron BTW).
    I also think Invivo will keep saying they are working on a therapy for chronic, but they are not really doing it.
    They may just buy technologies developped by others for chronic SCI if someone comes up with something that looks like a big profit opportunity.

    I will be happy if my predictions here above will turn out to be wrong. People will then be free to punch me on the face.. with a wheelchair

    - In order to be effective, truth must penetrate like an arrow... and that is likely to hurt -

    So if what I say is true it will hurt someone and that's good (sadly) as we need to start from the truth to support the scienze that is really directed to get us out of chair.

    Paolo

  8. #8
    Quote Originally Posted by paolocipolla View Post
    c473, you are for sure much wiser than me.
    I am very radical (sometimes). I do that as there are enough people who nicely follow the mainstream and that's not good to stay connected with reality.

    My prediction is that INVIVO may get this neuroprotective "product" for SCI on the market and then they will move on more prifitable markets than SCI, just like ACORDA or Geron did. (Same will do the company who has bought stem cell technology from Geron BTW).
    I also think Invivo will keep saying they are working on a therapy for chronic, but they are not really doing it.
    They may just buy technologies developped by others for chronic SCI if someone comes up with something that looks like a big profit opportunity.

    I will be happy if my predictions here above will turn out to be wrong. People will then be free to punch me on the face.. with a wheelchair

    - In order to be effective, truth must penetrate like an arrow... and that is likely to hurt -

    So if what I say is true it will hurt someone and that's good (sadly) as we need to start from the truth to support the scienze that is really directed to get us out of chair.

    Paolo
    Hi Paolo!

    In this video: http://watch.bnn.ca/the-close/the-cl...13/#clip915623

    He mentions great results in chronic injured monkeys (at 5:40), just bullshit then?
    Debating on CareCure is like participating in the special-olympics. You may win, but you're still disabled.

  9. #9
    Quote Originally Posted by void View Post
    I know about the distrust here towards Frank as person but not towards the actual research. Could you please elaborate your scepticism, and which of their work do you believe in? Just interested in hearing points raised not concerning the person.
    Deep down I pull for all to work out. I remain skeptical about the Korean stem cell procedures, those in Mexico and in the Dominican. I have seen too many go and pay large dollars and return with no changes. With Invivo I simply just do not understand how a scaffold can prevent further damage so I doubt. Hopefully I end up wrong.

  10. #10
    Quote Originally Posted by void View Post
    Hi Paolo!

    In this video: http://watch.bnn.ca/the-close/the-cl...13/#clip915623

    He mentions great results in chronic injured monkeys (at 5:40), just bullshit then?
    I can't see the video, but I have seen him mentioning chronic SCI many times before. Yes, I think it's just BS.
    If these results were real he would provide more details about that and maybe (why not?) publish the data.
    That would get the SCI community all behind Invivo and the share prize would skyrocket.
    And he is not the kind of guy who tend to underpromise and overdeliver. So far he has done the opposite.

    Paolo

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