Ann: Positive topline results from SAR-bisPSMA diagnostic trial, page-3

This is one of those announcements that only experts understand. I know why they have held back all the juicy data (it is embargoed and will be presented in ASCO in Feb), but this does not make it easy for the average investor to understand what a big result this is.

The two key read-between-the-lines items are meeting all primary and secondary endpoints and the data being used to plan the definitive Phase III clinical trial. 68Ga does not have the sensitivity to detect small primary lesions and this trial was designed to see if 64Cu could. This is  explained by John Hester in his latest Bell Potter report quoted below.


While we haven't been told directly by CU6 that they met the sensitivity level requirement (this will come in Feb at ASCO), we have been told indirect via the announcement that they are going to use this data to run a Phase 3 trial in 2023. The FDA would not let them run a Phase 3 trial (nor would anyone who is sane try) unless they had data from this trial showing they reached the needed level of sensitivity. All-in-all an extremely positive result that the market has again missed.