Sareum Holdings - SDC-1801 CTA application hits a roadblock

Sareum has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has turned down the clinical trial authorisation (CTA) for SDC-1801 based on the submitted data package. While Sareum awaits the formal letter of non-acceptance, initial insights suggest that the MHRA will seek a review by the UK Good Laboratory Practice Monitoring Authority or request additional information to support the submitted non-clinical data. As a reminder, Sareum filed the CTA for SDC-1801 in July 2022 with the intention of commencing the Phase Ia trial in Q4 CY22. While the company is seeking further clarification from the MHRA on the requirements for resubmission, we now anticipate a delay in launching clinical activity.

Den vollständigen Artikel lesen ...