It goes back to their 2017 PR about in order to data lock, they need to visit every one of the Phase III clinical sites.
“In this process, all data from all of the treatment visits and follow up visits for all 331 patients in the Trial, must be subjected to quality control checking. The process involves in-person monitoring visits to all of the 80-plus sites in four countries to review the files onsite, as well as other documentary confirmation and checking of all MRI images. As such, it is a multi-month process. While this process is under way, OS and PFS events will continue to accumulate.” — Feb 2017 NWBIo PR
Most of us believe they started the data lock process of reviewing data at clinical sites back in early 2017, as reported. Each clinical site had s specific patient recruitment count target. Once that target was hit, recruitment closed. Once recruitment closed at a site (every site would be different) it would be 3 years after last enrolled patient that they could scrub the primary endpoint data at the clinical sites. As an example, UCLA began recruitment once the trial resumed in the summer of 2011. Since UCLA was one of the earliest clinical sites within the trial they likely reached their 28 patient enrollment target in 2014. That would be one of the sites they easily could have visited in 2017 and completed the primary endpoint quality control checking. NYU was another site that closed recruitment years ago. The list of opened then verified closed sites is long. As such, it may only the last in sites that we have to wait for them to visit now. Hopefully they never stopped this quality control checking as our wait is dependent on that.
