Biotech Values

[iwfal]

In May 2010, the FDA issued the sponsor a Complete Response letter for the sunitinib PNET efficacy supplement.

Good conversation. Agree. Just for the purposes of the thread, they also got approval a year later using a reanalysis of the same data. This, of course, shows the risk of this approach - although I think it probable the delay would have been a lot less had the p value been more extreme (it was 'only' 0.00012).

Also, note that, in the vein of this thread, 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.


And, finally an FGEN comment. Given the size of the trials they halted, and their duration, they could actually get 'stat sig' (i.e. p<0.05) on them as individual trials with only a moderate efficacy in MACE or OS. It may be part of the calculus of stopping one dialysis and one non-dialysis while over-enrolling on most (all?) of the rest.