The report briefly alludes to "quantitative" for Sepsis but doesn't expand on how harmful that need is for the company's prospects in the foreseeable future.
Covid / Flu-A / Flu-B are all pass/fail tests - with much smoother regulatory processes.
Sepsis must be quantitative AND show clinical relevance as predictive of clinical outcome. It can't just demonstrate equivalence to some other measurement system.
ADO stuffed up the approvals for the simple test. Sepsis is an entirely different game. Shareholders have previously mulled over the TGA requirements for Covid RATs ... the requirements for Sepsis don't even exist yet.
Ann: Quarterly Update and Appendix 4C, page-18
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