I think it's possible the FDA may take that view, i.e., that another trial is warranted in low GFR patients.

However, they might also go ahead and approve the use of apabetalone in low GFR patients, given this was a prespecified subgroup analysis, coupled with the magnitude of the apparent beneficial effect.

Their decision might depend on how well matched the the two low GFR groups were. Off hand, i cannot recall if what is known as stratified randomisation was used for this apsect of the trial (patients being divided into low and high GFR groups prior to being randomised to placebo or apabetalone).