Biotech Values

[jq1234]

>> Just for the purposes of the thread, they also got approval a year later using a reanalysis of the same data.


It wouldn't have been approved if PNET weren't very rare oncology indication and Sutent weren't approved previously for other indication.


>> there are plenty of trials that DSMBs allow to go to completion even though they clearly had very low p values at a significantly early point in time. So even very low p values is not always considered an acceptable reason to halt.


Give me one example of this happening from registration trials. Other trials not for registration purpose don't count in this discussion - most likely reason of not stopping is without pre-specified stopping rule that is taking consideration of sample size, events and p value. Companies just don't take that type of chance in setting up DSMB Charters for registration trials today.