I honestly depends on how long it takes them to go through PFS data and lock down all clinical sites.
I’m of the opinion that they started this site visit PFS data lock process years ago (as reported in 2017) and visited closed clinical sites that only had follow-up period to do on patients — meaning sites like NYU that enrolled all their patients early on and did not have any more patients in the “active” phase of the study. These would be sites that enrolled patients prior to 2014 (ended enrollment 3 years or more). Patients that remained alive in any site would still be subject to their 3 month follow up OS calls and every 3 month scans (I don’t believe they are 2 mints at that point). But the Company had to stop visiting closed sites when they ran low on funds. Let’s say they visited 20 in the past. They would have to go back to those. They would just have to complete the process on the other 60 or so clinical sites. Now this process of visiting clinical sites (to close out the PFS patient data) resumed in the New Year (2019). We don’t know how many they have left to do but I suspect it’s more than half of the enrolled clinical sites. Depending on how many patients would be recruited at the sites will determine how long it takes to lock the PFS data for that clinical site. OS data would remain open on however many patients are alive and they would still be doing 3 follow-up calls and OS continue to mature until they are ready to do officially end the trial. Only difference is they would be recording that survival update every 3 months, up until the end, depending on when patients were enrolled. Once they complete all the PFS data lock on all the clinical sites, they are ready to do their final wave of OS calls. That would occur just after PFS data lock. It shouldn’t take more than a few days to reach the patients that remain alive. But they definitely won’t want to lose patients to follow-up so if they can’t get the patient we may have to wait for them to exhaust the follow up process before they data lock OS data and do analysis on both. We would only hear report of PFS data lock once. And SAP should take place shortly thereafter, but only once they lock OS data.
Flip feels reporting by Sept is more than reasonable time frame to data lock PFS data, data lock OS and do the SAP. Without knowing how many sites they completed in 2015 it’s really hard for me to say whether they’ll be done by then. But I do think 8 months should be sufficient to visit 40-60 sites (between 1 to 3 a week, depending on location). I won’t be surprised if we are waiting into Sept. Feel if they are not going fast on site visits we will end up getting 4 years of OS data from surgery on all patients and they may be purposely going slow to age the OS data.
