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Thursday, May 24, 2018 2:38:28 PM
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.
They reach the Os threshold and still no data lock. To this day no data lock announced.
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