French Trial Tragedy: Who Says What Data Should Be Published?
This article was originally published in SRA
Executive Summary
While French government inspectors pore over the results of their recent visit to the premises of Biotrial, the CRO that ran the ill-fated Phase I study with the FAAH inhibitor BIA 10-2474, the regulatory agency ANSM has revealed that the product's developer, Bial, has opposed the publication of the preclinical documentation on the drug1.