https://www.maunakeatech.com/upload.../aa2f72e8f02e4d2ba4e4a76950ecee33ae7362a6.pdf
A bit of related reading while we are waiting.
This is from an early 2018 Mauna Kea presentation, we are referenced on page 23.
Seems Mauna Kea are also awaiting FDA in 2018.
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https://www.maunakeatech.com/uploads/media/media_pdf/0001/02/aa2f...
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