AXP axp energy limited
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As they are using DeNovo process after working with FDA for IDE...

  1. imback
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    29/01/16
    13:45
    Post #: 16895648
    As they are using DeNovo process after working with FDA for IDE and endpoint requirements, I have little doubt it will go through. This is not a PMA which is a heavy duty approval process. Sometimes, additional information may be requested by FDA which can slow the process by 1-3 months.

    They previously had a EU CE-Mark quality system in place and this will de-risk getting any unexpected basic documentation issues.
    AXP Price at posting: $1.28 Sentiment: None Disclosure: Held
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    lightbulb Created with Sketch.  Great analysis
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