" I do wonder why a company would set a single interim so low"
Agreed. There is no point doing an interim using so conservative an alpha spent unless one has the following in mind:
1. Sometimes to pursue an accelerated approval based on a positive surrogate endpoint, one would need to submit the survival analysis to FDA before it's fully matured. 2. When a futility boundary is also in place. 3. To make the final analysis more legitimate if the Data Monitoring Committee wants to look at OS during the interim to spot a numerical deficit in survival. 4. A diversion for investors during a data drought.
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