date:Aug 28, 2012
the relevant field,the NDA wrote in its response to the Clasado appeal.
The NDA also mentioned correction for multiple outcomes and backed its initial assessment that there had been inappropriate statistical analysis for cross-over design.
It is noted in the Opinion that, in response to EFSAs request for the full study report and a statistical re-analysis of the data which would be appropriate for cross-over designs, the applicant provided a brief summary report including limited information