CU6 - Media and Industry News, page-987

Thank you, but I was referring to lesions. I don't think you're getting my point.

Patients A and B are scanned by the SOC and cu64. In each patient;
- the SOC picks up 4 x 5mm lesions
- Cu64 picks up 4 x 5mm lesions and 6 x 2mm lesions
- Two of the 2mm lesions are biopsied and prove positive. The other 4 are not biopsied as the burden on the patient would be deemed unethical.

Since the other 4 x 2mm are not picked up by the SOC and are not biopsied, they default to be classified as false positives. Cu64 has a 40% false positive rate.


Six months later ...

Patient A was not given any treatment since the original scan. They are scanned again using the SOC. The 6 x 2mm lesions have all grown to 5mm and the SOC picks up all 10 lesions. All of the false positives are now confirmed positives. Cu64 now has a 0% false positive rate.

Patient B was treated after the initial scan. They are scanned again using the SOC. Due to the treatment, none of the 2mm lesions have grown so are still not picked up by the SOC. Cu64 is still (incorrectly) classified as having a 40% false positive rate and 6 months have been added to the cu64 trial for no benefit (in fact the 6 months added have made the situation more misleading).

The point I'm making is that instead of re-testing 6 months down the track, if enough patients and enough lesions that are negative SOC / positive cu64 are biopsied, then a true false positive rate can be established without waiting 6 months for a second test that becomes irrelevant since there is no control on whether the patient has or hasn't been treated in the interim.

Having said all this, please don't do any more research on this issue on my behalf. It would have been good to understand the process in order to get a better understanding on how long these diagnostic trials might take. I wasn't the only one confused. As I noted previously, in December 2023, Wilsons expected commercialisation of a diagnostic product in 2025, so they also seemed to have misunderstood what Clarity planned.

In the most recent Frazis interview, Alan confirmed no commercialisation before 2027 or 2028, so irrespective of any view of the trial protocol, the bottom line is the bottom line ...