Hey that is excess mortality in the treatment arm. That is not good. A hold because of an adverse event is one thing, but this is a hold because treated patients are doing worse than controls.. What are the chances of ever re-starting a trial with that outcome???
Overall survival data are premature, but a landmark analysis at week 24 found that spleen shrinkage was associated with improved survival in the pacritinib arm but not in the control arm... well that's a bit sneaky right? Those that had reduction in splenomegaly had (were associated with) increased survival, fine, but that could have been outweighed by decreased survival in those without reduction in splenomegaly who died from severe AE. This is telling: The Independent Data Monitoring Committee (IDMC) for the PERSIST-1 program recommended patients on the best available therapy arm should not crossover to receive pacritinib due to non-statistically significant safety concerns in patients who crossover after 24 weeks, which crossover confounds evaluation of survival. hmmm. not quite a lie but.
you would think that would be something they would have been required to disclose. This is one class action that makes sense.
the recovery in price is beyond absurd. human investors are lemmings. all efficacy data are lost when study closed early. will need to start over if and when fda finally lets a new trial start. but why bother cause by then there will be 5 competitors on market.
this drug is one microstep from having no data at all - just endorsements like those on the label of OTC erectile dysfunction therapy.
I think the idea of having drug approval based on testimonials is just grand.
expected to do better than the historical average? All my students knew today's outcome. We have been using this as a case study for EBM for several years, ever since the first data were distorted.