ATH alterity therapeutics limited

Ann: ATH Presentation Tracking MSA Progression at Intl Symposium, page-21

  1. 141 Posts.
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    Rewatching this the Q&A gives some good insight into Stamler's thinking on 201. That he does feel that 201 could support an accelerated approval, but it wouldn't be off iron reduction alone, that perhaps FDA would accept reducing brain volume loss. Surely these would need to line up with UMSARS too.
    What's a bit unclear is if Alterity would need to change the 201 primary outcome to include brain atrophy before readout. Potentially they have decided against adding it, or are waiting to meet with FDA like they had hoped before deciding. If the atrophy trends line up nicely with current outcomes, like 202 interim results suggests it does in the responders, you'd hope FDA would consider it supportive regardless if it's a given outcome or not.
 
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