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Thread: InVivo Therapeutics Corporation Files FDA Application

  1. #1
    Senior Member Leo's Avatar
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    InVivo Therapeutics Corporation Files FDA Application

    Published Friday, December 4, 2009, 0:43 (Your-Story.org)

    InVivo Therapeutics Corporation Files FDA Application for Human Studies for Spinal Cord Injury Treatment

    CAMBRIDGE, Mass.–(BUSINESS WIRE)– InVivo Therapeutics Corporation has filed an Investigational Device Exemption application with the Food and Drug Administration requesting permission to advance to human clinical studies. InVivo is currently conducting its third primate study and expects to receive approval to begin a human study in 2010.

    CEO Frank Reynolds is confident in the company’s chances of receiving approval, and is optimistic about what obtaining a regulatory green light represents for spinal cord injury research, making InVivo’s technology the first treatment of its kind to progress to clinical studies.

    http://www.your-story.org/invivo-the...eatment-63929/
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  2. #2
    Senior Member lunasicc42's Avatar
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    am I missing something? Is this suggested for acutes?
    "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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  3. #3

    InVivo Therapeutics files an Investigational Device Exemption application with the FD

    scroll down to read the article.


    InVivo Therapeutics files an Investigational Device Exemption application with the FDA

    December 4, 2009

    InVivo Therapeutics Corporation has filed an Investigational Device Exemption application with the Food and Drug Administration requesting permission to advance to human clinical studies. InVivo is currently conducting its third primate study and expects to receive approval to begin a human study in 2010.

    CEO Frank Reynolds is confident in the company’s chances of receiving approval, and is optimistic about what obtaining a regulatory green light represents for spinal cord injury research, making InVivo’s technology the first treatment of its kind to progress to clinical studies.

    According to the Christopher Reeve Foundation website, there are “nearly 1 in 50 people living with paralysis -- approximately 6 million people.” Of this, 1,275,000 cases, or twenty-three percent, are the result of spinal cord injury.

    read...

    http://www.news-medical.net/news/200...h-the-FDA.aspx

  4. #4
    12/4/09 - InVivo Therapeutics Corporation Files FDA Application for Human Studies for Spinal Cord Injury Treatment


    CAMBRIDGE, Mass.(BUSINESS WIRE) InVivo Therapeutics Corporation has filed an Investigational Device Exemption application with the Food and Drug Administration requesting permission to advance to human clinical studies. InVivo is currently conducting its third primate study and expects to receive approval to begin a human study in 2010.

    CEO Frank Reynolds is confident in the company's chances of receiving approval, and is optimistic about what obtaining a regulatory green light represents for spinal cord injury research, making InVivo's technology the first treatment of its kind to progress to clinical studies.

    According to the Christopher Reeve Foundation website, there are nearly 1 in 50 people living with paralysis approximately 6 million people.? Of this, 1,275,000 cases, or twenty-three percent, are the result of spinal cord injury.





    more...
    http://www.pharmacychoice.com/News/a...icle_ID=497780

  5. #5

    Unhappy

    sorry leo, I post it too fast without checking first.

  6. #6
    Senior Member Leo's Avatar
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    December 15, 2009 10:05 AM Eastern Time
    George Nolen, Recently Retired CEO of Siemens Corporation, Joins InVivo Therapeutics Board of Directors

    CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Corporation has added George Nolen, former President and Chief Executive Officer of Siemens Corporation, to its Board of Directors. The Board approved the appointment on Friday, December 11th.

    InVivo Therapeutics Chief Executive Officer Frank Reynolds is looking forward to reuniting with Nolen. During Reynolds’ time at Siemens, Nolen was his mentor in the high potential candidate pool.

    “I’m very excited to be part of something that will help so many people around the world and provide some relief for the enduring suffering caused by spinal cord injuries,” said Nolen. “At Siemens I observed Frank’s success and I look forward to helping to guide InVivo’s success as we advance InVivo’s technologies to market”.

    http://www.businesswire.com/portal/s...24&newsLang=en
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    2010 SCINet Clinical Trial Support Squad Member

    "You kids and your cures, why back when I was injured they gave us a wheelchair and that's the way it was and we liked it!" Grumpy Old Man

    .."i used to be able to goof around so much because i knew Superman had my back. now all i've got is his example -- and that's gonna have to be enough."

  7. #7
    I'm very nervous that a cure for Acutes will result in a shrinking market for research companies to invest in a therapy for us Chronics!!

    There's no (autuism?) in Big Pharma.

  8. #8
    I hope I'm wrong!!!!

  9. #9
    Quote Originally Posted by malthouse View Post
    I'm very nervous that a cure for Acutes will result in a shrinking market for research companies to invest in a therapy for us Chronics!!

    There's no (autuism?) in Big Pharma.
    malthouse, the word I think you are looking for is "altruism". Don't be nervous. At the present, it costs over a billion dollars to move a therapy from laboratory to FDA approval. Any market that cannot generate revenues of over a billion a year will not attract the commitment of a company. The only way around this problem is to reduce the cost of developing therapies for spinal cord injury. Having better acute spinal cord injury therapies will not change the size of the chronic spinal cord injury market all that much in your lifetime. Wise.

  10. #10
    Quote Originally Posted by Wise Young View Post
    malthouse, the word I think you are looking for is "altruism". Don't be nervous. At the present, it costs over a billion dollars to move a therapy from laboratory to FDA approval. Any market that cannot generate revenues of over a billion a year will not attract the commitment of a company. The only way around this problem is to reduce the cost of developing therapies for spinal cord injury. Having better acute spinal cord injury therapies will not change the size of the chronic spinal cord injury market all that much in your lifetime. Wise.
    wise so what if it works?

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