pagina 34
For example, as part of the marketing authorization application process, we had a routine Good Clinical Practice inspection in September 2016. Following this inspection, we received an inspection report identifying certain critical and major deviations from Good Clinical Practices. We submitted our initial replies to the report from this inspection, including the corresponding planned "corrective and preventive actions", on October 21, 2016. We received the inspector's report to the EMA's Committee for Human Medicinal Products, or the Integrated Inspection Report, in November 2016, which indicated that the inspectors continue to be concerned about potential critical GCP deviations, in particular a potential violation of patient privacy due to the presence of a company-sponsored healthcare professional during the administration of Cx601. The inspectors recommended to the EMA that the data from the trial should be disregarded as part of the marketing authorization application. In making their recommendation, the inspectors focused on the infringement of the patient's right to consent to the presence of a company-sponsored healthcare professional.
Due to the nature of this finding, the inspectors deemed the trial not to be conducted in accordance with ethical principles, including GCP and applicable regulatory requirements. We will include our replies to the issues raised in the Integrated Inspection Report as part of our replies to the day 120 list of questions. If our replies are not deemed sufficient by the EMA, we may face additional consequences, including rejection of data or other direct action by national regulatory authorities, which could require us to conduct additional clinical trials or other supportive studies to obtain EMA approval.