Tuesday, February 07, 2017 10:00:41 AM
Data lock will occur on primary endpoint after they finish checking all the site data. The DMC will be overseeing statistical analysis on that endpoint data. The outcome will determine how the rest of the trial is treated. The company will remain blinded until that information is in. If it is statistically significant then they will pursue Accelerated Approval and the secondary endpoint will be the confirmatory one to try and gain full fledge approval. If it is not statistical significant then the trial will go to the end and see if the secondary endpoint is statistically significant the trial will go for regular approval. If they get regular approval they will need to run a confirmation trial. Unblinding will not occur until OS either way, as the secondary endpoint is either the confirmatory endpoint or it is a regular approval endpoint.
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