This all comes down to the design of the trial. The "problem" is...

This all comes down to the design of the trial. The "problem" is Cu64 is so much better than standard of care that it is finding tumours that SOC can't find. Imagine there are 10 real tumours present in a patient and SOC only detects 3 but Cu64 detect 9. Under the criteria of the Phase 2 trial, those 6 extra tumours detected have to be considered false negatives unless they are biopsied.

It looks like Clarity when they designed the trial didn't expected Cu64 to be so much better than SOC imaging. Using the example above, if Cu64 only detected 4 of the 10 tumours then the "false" false negative rate would have been far less of an issue.

This is about the best problem you can possibly have with a new diagnostic (i.e. it is vastly better than SOC). This false negative "problem" will be solved in the Phase 3 by changing the criteria of what is a false negative and only using the subset of tumours that are biopsy confirmed or not.

For those of us able to understand what just happened, we are being given a massive gift by the market.