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Re: io_io post# 5354

Monday, 02/04/2008 12:59:53 PM

Monday, February 04, 2008 12:59:53 PM

Post# of 12660
" 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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