Patrys’ Contract Development Manufacturing Organisation (CDMO) advised the Company that specification testing using a revised process is still not complete, and that the revised process is proceeding through Quality Assurance and Quality Control approvals. In view of this, the CDMO has advised that specification testing for the drug substance produced in the recent manufacturing run of PAT-DX1 is now expected to be complete in mid-September 2024. Specification testing must be successfully completed for drug material to be released for use in clinical trials and this delay will directly impact on the commencement of clinical development activities for PAT-DX1.
