Ann: FY22 Strategic Update, page-5

I have no doubt that they do keep an eye on the hc threads. Twice now I have posed a question on hc and fairly promptly afterwards the direct answer to my question has been included in a RHY ASX announcement. It is one of the things that's impressed me about this management: they keep the news flow coming at a regular rate and they do, for the most part, try to answer the questions we have (the reason why it has taken so long to recruit 1,000 patients for Study 7 - when there are 800,000 colonoscopies done in Oz each year - remains a bit blurry.

Study 7 was supposed to be completed before COVID hit and developing a final ColoSTAT product seems not to be on the critical path of the study).From today's announcement it seems they have not been testing the samples from Study 7 with ColoSTAT but have been storing the samples for testing at the end of the study using the latest version of ColoSTAT (or at least they are keeping some of the samples for final testing).

A few take-aways for me:
1. it does appear there is an advantage for a US based company to apply for approval from the FDA hence their setting up a US domiciled entity.
2. I am chuffed with the confirmation that they intend to apply the biomarkers and algorithm developed for colon cancer to other types of cancer. Though I am not sure why they need a separate entity for this work, as on the one hand they say it should not be capital intensive but on the other they talk of "collaboration" and grants.
3. Seems that Europe might be first cab off the rank as it does not require Study 7 results, with CE Mark filing late this year and revenue to start flowing by late next year.
4. Might just be awkward wording but I get the impression they are now saying that the local regulator, the TGA, will require the Study 7 results.
5. They undertake to keep the news flow coming, providing milestones and deadlines as they go.

And this is the statement I think I will be able to take to the bank:

"ColoSTAT will transform the global mass-market cancer diagnostic market".