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Ann: Positive Results for Australian Prospective Paediatric Study, page-148

Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #
  1. Tech goose
    2,706 Posts.
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    03/09/18
    16:15
    Post #: 35380763
    Well understood regulatory pathway
    - Held US FDA Pre-Submission meeting in Q1 CY2016, confirmed de novo regulatory pathway strategy
    - FDA submission following US pediatric study completion
    - CE (Europe) and TGA (Australia) submissions following Australian prospective study completion

    That’s Mr Genius to you.....your argument was sorted our back in Q1 2016.
    RAP Price at posting: 23.0¢ Sentiment: Buy Disclosure: Held
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    lightbulb Created with Sketch.  Great analysis
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