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    • #17654

      Reata announces that the FDA has asked the company to request a Pre-NDA Meeting for Omaveloxolone for the treatment of Friedreich’s Ataxia.

      The FDA’s request for a Pre- NDA meeting demonstrates the power of the community’s unified voice. The FDA is demonstrating flexibility, being open to additional data analysis, and considering the patient voice in the drug development process. We are also grateful to Reata Pharmaceuticals for their steadfast commitment to the omaveloxolone program in FA. FARA looks forward to working with both Reata and the FDA in the next steps of the process and keeping the community informed.

      Read the full press release here:

      https://www.reatapharma.com/investors/news/news-details/2021/Reata-Announces-that-The-FDA-Has-Asked-The-Company-to-Request-a-Pre-NDA-Meeting-for-Omaveloxolone-for-the-Treatment-of-Friedreichs-Ataxia/default.aspx

    • #17659
      Karina Jeronimides
      Participant

      This is good news and I applaud our community for its attempts at moving this sleeping giant called the FDA who will only make exceptions to cure people like Trump and Giuliani.  I am still rather depressed as after 30 years with FA, finally, a drug that palliates the devastating effects of FA is discovered.  But for it to take 2 years just to get the FDA to agree to another meeting [which will take forever and which they will just deny things again while I m still breathing] to re-evaluate the drug’s effectiveness is extraordinarily depressing.  It’s difficult to carpe diem when one is sleep deprived from spasms and neuropathy that wake me up 7 times t night or constipated or having incontinence and wearing a diaper.  I hope they all get FA.

    • #17722
      Katherine
      Participant

      I’m with Karina.  They’ve been trying to build hype about a lot of drugs for a long time, but nothing has come of any of them.  I refuse to get excited about anything until I can put it into my body.

      I’ve decided to live the best life I can under the assumption that they’ll never find a cure.  If I’m wrong, I’ll be pleasantly surprised, but I’m not going to pin all my hopes on that.

    • #17725
      David Riley
      Participant

      I don’t intend to do virtue signaling, and I hate how mass media does it so much these days in the politco-social context.

      But I will live my best life now, which involves hope for a treatment. Far from being just virtue, it is also a pragmatic response. Hope is a positive attitude, and this kind of positivity lets the chemical functioning of the body work at a higher level.

       

       

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