Maxer anonymizes and redacts the Oxervate dossier
Maxer Consulting announces to have implemented the anonymisation and the redaction of the commercially confidential information for the pivotal and the support studies that Dompé Farmaceutici submitted to the Committee for Medicinal Products for Human Use (CHMP) for the registration of Oxervate (cenegermin), indicated for the treatment of adult patients with moderate or severe neutrophilic keratitis.
In consideration of the relatively limited number of patients treated in the studies and of the non-maturity of the anonymisation software, the Maxer team adopted the non-analytical method, masking the identifiers and part of the quasi-identifiers; the anonymization report concerning the studies in scope describes this procedure. Moreover, the Maxer team identified the information that Dompé Farmaceutici indicated as commercially confidential and proposed their removal from the studies, explaining the rationale for the request in the justification table foreseen in the EMA policy 0070/2014.
