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    • #23670

        In December (2022) when I was officially diagnosed, the research team in Miami applied for Early Access/Compassionate Care for me to receive Tofersen. I initially thought that it would take 30 days or less because the legislation says the FDA will review the application in 30 days or less.  This is a much longer process than I had ever anticipated.  So apparently, because I’ve been volunteering for research the medical staff also has other hoops (on my behalf) to jump through. There is an internal review board application, as well as the application to the FDA which is handled by a different company than the pharmaceutical company (Biogen).  I was diagnosed Dec 2nd.  They completed the applications before Christmas, and I received an email yesterday saying that as soon as the Internal review board approves my application they will forward it to Biogen and then the drug will be shipped.  They hope that this will happen at the end of the month.  Boy, that 30 day statement really had me fooled.  If this is an expedited process they really need to streamline things. Many people would not have survived 4 – 5 months or they may have lost significant muscles.    So, as of now I am hoping and praying that this end of the month timeline is real. I’ve heard positive things about Tofersen.

      • #23672
        Tina Johnson



          I had my team start the application process end of December. Still nothing. I ask every so often for any updates and get the answer they haven’t heard anything. It’s so frustrating.  All I do is hope and pray everyday.



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