Yes. Sometime in Nov makes the last patient enrolled for 36 months. There is still the multiple month process to data lock. I don’t think it will take 3 months again, but it could take us into the new year. Basing my opinion on NWBio statement from the Feb 2017 PR - which incidentally they alluded that the trial is going through a current data scrub now even in their most recent PR.
“There are 331 patients enrolled in the Trial. The Trial endpoints involve thresholds of 248 “events” for PFS and 233 “events” for OS. PFS events are primarily tumor progression (i.e., recurrence), although they can occasionally be patient deaths which occur without prior evidence of tumor recurrence. OS events are patient deaths. The PFS and OS events are continuing to accumulate as the Trial continues. The PFS events have surpassed the 248-event threshold, but the OS events have not yet reached the 233-event threshold. Based upon the pace of OS events during the last six to eight months, the Company’s current anticipation is that it will be several months until the Trial reaches 233 OS events.
Dr. Linda Liau, Principal Investigator of the DCVax®-L Trial commented: “It is gratifying to have the hold removed from the Trial and exciting to see this Trial now moving towards completion, although of course the longer it takes for PFS and OS events to accrue, the better the patients in the Trial are doing.”
The external parties managing the Trial are now moving forward with the process to reach data lock. 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.
The Trial will reach data lock when the threshold events have been reached and the quality control checking has been completed for both the PFS and OS endpoints.
When data lock is reached, external statisticians and experts will make an independent analysis of the Trial data. The Company will remain blinded until data lock has been reached and the external data analysis has been completed.” — Portion of Feb 6, 2017 NWBio
And most recent press release confirms that they are going through an entire trial sweep right now. Sure they could data lock once it’s done. And if they seriously run out of a way to raise money without going to toxic spiral lenders, they might choose to unblind this summer, with the data aged another year. But I don’t think that will happen. I believe they will just report it, and then use that data to present another blinded blended data update in December 2018 at ANO Conference, as we early wait for the true unblinding to occur following the last patient in passing the 36 month / consent period end of the trial.
“The reported data are from the most recent prior full data collection in 2017. The Company is undertaking another full data collection, which is a multi-month process and will be continuing over the coming months.” — May 29, 2018 NWBio PR
They have lots of data that they could give us an post-hoc update on. For instance, it would be good to know how long and fat the tail for the PsPD in the compassionate use arm patient arm are soon.
Yes, on those warrants.
