Posted by Michael Wonder on 18 Feb 2023
Reata’s ‘toss up’ drug approval decision is in the unpredictable hands of FDA’s Billy Dunn
17 February 2023 - In the aftermath of the FDA’s Aduhelm debacle, the agency’s neuroscience chief Billy Dunn has another controversial approval decision to make.
It will once again test his willingness to apply the FDA’s doctrine of “regulatory flexibility” to a medicine with less than convincing clinical data.
