Replies to post #118131 on Biotech Values

[iwfal]

This was not an efficacy halt, and that is the whole problem.

The DSMB can request a halt when EITHER arm is doing bad for safety reasons. That is what happened.

? It was a halt on the pre-defined primary endpoint (PFS) - just not at a planned interim. It was the primary endpoint going the correct direction. It was not 'safety' - which is typically used to mean everything but the primary endpoint going the right direction. It is precisely the situation I asked about in the below thread and found no examples - so this will be a good test case.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58789607

[jq1234]

This was not an efficacy halt, and that is the whole problem.

It is, just not planned one.

The DSMB can request a halt when EITHER arm is doing bad for safety reasons. That is what happened.

Sure. But the comparator arm is placebo here, if the testing drug works, what do you expect? There should be inbalance of death between two arms in this case.