I'm unsure what the regulatory submission relates to. FDA is still attractive, even though it's not flagged as the initial pathway. Is it conceivable to take a parallel approach?
Concerning the additional cancer detections my interpretation is the "years to weeks" comment relates only to the discovery stage of biomarkers. Once biomarkers are identified (in weeks perhaps), the proof of concept, or patient testing, needs to take place which is much more time consuming. In any event I see this as a bit of cream on the side. ColoStat is front and centre for me.
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News: RHY Rhythm Biosciences Files With TGA To List Colostat On Register Of Therapeutic Goods, page-58
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