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