Relief Therapeutics Holding AG (RLFTF)

[changes_iv]

The EMA and the FDA had high concordance (91–98%) in decisions on marketing approvals. Divergence in approval decisions, type of approval, and approved indication were primarily due to differences in agencies’ conclusions about efficacy based on review of the same data or differing clinical data submitted to support the application. This high rate of concordance suggests that engagement and collaboration on regulatory science has a positive impact.

https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.1565