ATH alterity therapeutics limited

Ann: Alterity Granted U.S. FDA Fast Track Designation for ATH434, page-68

  1. 136 Posts.
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    Yeah bit of patience still required it seems. We need to get our end of phase 2 dossier completed, analysing and understanding 201 (and likely 202 too) results - could still be couple months. Then apply for EOP2 meeting with that dossier and complete the meeting/get feedback ~2 months later. If EOP2 goes well and FDA is encouraging AA then we get full new drug application dossier completed and submitted, hopefully only adding 1-2 months, then wait the 6-9 months for FDA and review committees to review submission and say yes/no. So 8-12+ months from now. Thats my quick thinking roughly aligning with your Grok answer Groins. Maybe it all happens quicker now we have fast track.

    Hoping for some new data this weekend at MSA conference in Boston. Cheers
 
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