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Dr. Young question about anti-lingo

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  • Dr. Young question about anti-lingo

    Hi Wise,

    Just left my neurologists office. We were discussing Anti-lingo. Why would a USA company like Biogen Idec do the clinical trials in Australia rather than the US when FDA approval would take years to get here?
    Thanks for any info. Susan
    "What has happened, has happened; What I am going through, I shall rise above; And what will come, I will meet with courage"~Hazrat Inayat Kahn

  • #2
    Originally posted by Snuz View Post
    Hi Wise,

    Just left my neurologists office. We were discussing Anti-lingo. Why would a USA company like Biogen Idec do the clinical trials in Australia rather than the US when FDA approval would take years to get here?
    Thanks for any info. Susan
    Susan,

    I am not sure why Biogen is doing it in Australia. It is likely that they have a clinician there who is very willing and interested. They may not have a similar interested clinician in the United States.

    Anti-lingo is an exciting therapy, in my opinion. We are hoping to have an opportunity to test the drug in ChinaSCINet and perhaps in SCINetUSA as well. But, the first trial is likely to be a phase 1 trial (to assess safety).

    We cannot do phase 1 trials of non-Chinese therapies in ChinaSCINet. The Chinese government passed laws to prevent international drug companies going into China and using Chinese patients as guinea pigs.

    If and when the treatment passes safety parameters in phase 1, it can go into phase 2 and 3 trials in China and the U.S.

    Wise.

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    • #3
      Thanks Wise!

      My neuro was pressed for time and I know you know everything about all the research. I would love to participate in trials when it is done in the US! I'll be watching this. Thanks again, Wise!
      "What has happened, has happened; What I am going through, I shall rise above; And what will come, I will meet with courage"~Hazrat Inayat Kahn

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