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?
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