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I am thinking the accelerated FDA approval would be after the 24...

  1. pi065509
    1,035 Posts.
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    06/06/24
    22:06
    Post #: 74203977
    I am thinking the accelerated FDA approval would be after the 24 weeks and interim analysis, only for USA, EU don’t do accelerated approval. The trial would still have to run its course, 48 weeks for full approval, but PAA could still market the drug during this period, that is what occurred with Amylyx for RELYVRIO I think, I could also be wrong.
    PAA Price at posting: 20.5¢ Sentiment: Hold Disclosure: Held
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    lightbulb Created with Sketch.  Great analysis
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