Biotech Values

[poorgradstudent]

RETA:

Absolutely bearish on this. Their drug actually worsened outcomes in CKD (published in NEJM), and now they're trying to find a niche where increasing GFR will be sufficient.

The company claims they've identified the baseline characteristics of patients that were likely to be harmed by the drug. In effect, it was a subgroup that ostensibly drove the adverse events. Now they're omitting that subgroup in future trials.

It does raise one interesting question: are retrospectively defined subgroups more reliable for AEs than they are for efficacy going forward?