Thursday, June 27, 2019 2:38:19 PM
More about my talk with DI (that I now recall).
1. First I would like to repeat what I wrote a few minutes ago. Hopeforthefuture was right that if and when a data lock is installed it will no longer allow new results to be entered into the data base. However, no soft lock is yet in place. DI strongly hinted that a soft lock will be installed in the future because he hinted that there will be a period before data lock when no new data will be accepted (had to decipher the Rosetta stone for that).
2. I am pretty sure that there will be a soft data lock in the future but in the meantime we have the data almost all the way up to 47 months past the last patient's surgery.
3. Got the impression that DI believed that ALA was not extensively used in the last part of the trial and I believe he felt that would not be a major reason for improving the survival rates of the last third of the trial.
I also got the feeling that DI did not believe that any SOC treatment used in the trial including the improved surgical techniques was radically different than previous SOC and therefore on that account the survival results are not likely to be better than usual. Of course like us he cannot foresee the effect of the crossovers. Like all of us he is waiting for unblinding and then we all will know.
1. First I would like to repeat what I wrote a few minutes ago. Hopeforthefuture was right that if and when a data lock is installed it will no longer allow new results to be entered into the data base. However, no soft lock is yet in place. DI strongly hinted that a soft lock will be installed in the future because he hinted that there will be a period before data lock when no new data will be accepted (had to decipher the Rosetta stone for that).
2. I am pretty sure that there will be a soft data lock in the future but in the meantime we have the data almost all the way up to 47 months past the last patient's surgery.
3. Got the impression that DI believed that ALA was not extensively used in the last part of the trial and I believe he felt that would not be a major reason for improving the survival rates of the last third of the trial.
I also got the feeling that DI did not believe that any SOC treatment used in the trial including the improved surgical techniques was radically different than previous SOC and therefore on that account the survival results are not likely to be better than usual. Of course like us he cannot foresee the effect of the crossovers. Like all of us he is waiting for unblinding and then we all will know.
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