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Thursday, October 19, 2017 1:18:28 PM
It means that they are still accumulating events and other data. Why? Possibilities are:
1. There is a subgroup of subjects with long survival and they are still following it. A very good thing.
2. Hazard ratio for overall survival in L-sarcomas may be in need of additional data points in order to stay on the good side ( below 1). A bad thing. Officials at FDA are on record of saying that HR over one for OS is a sufficient reason for non-approval if not caused by subsequent (salvage) treatment.
3. Trial population size was not that large. They may just want to get as many data points as possible. Makes results a bit more robust. neutral thing - but will prevent FDA nagging about it.
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