Thursday, July 23, 2020 4:11:17 PM
With 43 sites that have not signe-off by June 24, it it hard to understand how LP would PR three weeks earlier (June 2) that if by mid June all the data was not collected, she would consider a soft data lock. How can one pivot to even a soft data lock when 1/2 the sites have not verified all their data?
However, on second thought it is possible to data lock if all the sites that have not signed-off are only missing information pertaining to the very recently introduced IDH mutation project. Under those circumstances, the statisticians can begin working and the IDH mutation data can be analyzed later and then added to the results.
That is the only logical explanation I have justifying a move to soft data lock during mid June. It also would explain why so many sites that by now have been inactive for years, have not yet signed-off during June. I have the feeling that such sites completed their tasks years ago and that perhaps from March through July most of the 80+ sites have been brought back to life and were busy verifying the IDH mutation status of their former patients.
I believe that by now the 33 sites that were at different stages of signing-off, have done so. NWBO may or may not still be waiting for data from some of the 10 sites that during June have not yet started the sign-off procedure but hopefully we are there or close to there.
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