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Alias Born | 03/29/2014 |
Monday, June 24, 2019 7:24:33 PM
Soft data lock occurs in January 2019. Then they gather it and scrub it and answer queries and examine their navels or whatever else this tedious business entails while they wait for the SAP to be FINALIZED. And when the SAP is finalized, it's "etched in stone" and they can THEN unblind the data. But the data that has been scrubbed and that will be what forms the content of the hazard ratios and p-values and mid-points and k-m curve possibilities of survival, etc., etc., will be based on what happened previous to the soft lock. What happens between the soft lock and the formal data lock will be additional data that won't be lost, but won't be part of what makes up the formal unblinded trial data.
This is how I understand it and what I think DI is saying on his phone.
Dr. Bosch... ASCO
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