Dr. Loomba’s thoughts
“What the FDA wants is a safe drug that is efficacious. It does not want an efficacious drug that may be unsafe, Loomba explains.
We’ve made some dent in terms of imaging assessment,” Loomba adds. While these noninvasive tests may not completely match histology data and replace it immediately, there is increasing evidence these are reproducible efficacy endpoints, he says. Also, more likely than not, they will be able to depict the efficacy of treatment under investigation, he notes.
To succeed in the EMA’s two-stage improvement bar, a bigger sample size would be needed, Loomba says. But a larger sample size would mean the placebo response rate also increases, he adds. Loomba is working with a panel of NASH investigators on a manuscript that points out further mismatch between the two agencies. The paper would call for efficacy benchmark harmonisation.”
https://www.clinicaltrialsarena.com/analysis/nash-rohit-loomba/