1) - how does following up a patient six months later...

1) - how does following up a patient six months later demonstrate superiority over SOC? Isn't superiority measured around the time of the cu64 procedure? To demonstrate superiority over SOC six months later, wouldn't the patient need another SOC scan (and I don't believe this is part of the trial protocol).

I will use info from both the COBRA trial protocol as well as the DISCO Trial info that’s available.

a) THE FIRST SIGNAL: Per The DISCO trial information at https://clinicaltrials.gov/study/NCT04438304?tab=table - the initial SOC versus Cu64 initial scans are done days to weeks apart. In the Inclusion Criteria, it states: "Pre-study 68Ga-DOTATATE PET/CT scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SARTATE". So, its just over a month (not 6). The reference to 6 months (which comes from COBRA) was for a different reason, which might (or might not) apply to DISCO - touched on below.
It is worth noting that these DISCO participants were already known to have, or were suspected of having disease "... based on axial imaging (e.g. on CT and/or MRI and/or FDG) and/or biochemical evidence of NET". So, the FIRST signal suggestive of superiority comes from a Cu64 scan returning a POSITIVE result when the SOC 68Ga-DOTATATE PET/CT scan was negative!
But, could this be a FALSE POSITIVE scan? One approach that Clarity followed before is detailed in the COBRA protocol: In COBRA, Clarity added 90 day and 180 day timelines to 'allow' the lesions to grow to a level that SOC may be able to detect it.
This is the 6 months referred to, and YES, the patients did have another SOC - at 6 months.



b) The CONFIRMATION: In COBRA, as long as the first Cu64 scan was positive, it became a matter of waiting until the SOC caught up and turned positive, or perhaps a biopsy got done and it confirmed the presence of cancer. Once that happened, the Cu64 result was confirmed as a TRUE POSITIVE and superiority on sensitivity was thus confirmed.
Clarity also got to be able to calculate how long it took for SOC to finally return a POSITIVE: A finding that is set to change the game.

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