Indehaverne af markedsføringstilladelserne var af den opfattelse, at de rejste spørgsmål under proceduren for gensidig anerkendelse angik den kliniske behandling og derfor ikke kunne afklares gennem yderligere kliniske undersøgelser.
The MAHs were of the opinion that the issues identified during the MRP were issues of clinical management and as such cannot be addressed by conducting further clinical trials.