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 Ju ....
09 Nov 2022
Sareum Holdings - SDC-1801 CTA application hits a roadblock
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Sareum Holdings - SDC-1801 CTA application hits a roadblock
Sareum Holdings plc (SAR:LON) | 24.2 -0.6 (-9.3%) | Mkt Cap: 24.6m
- Published:
09 Nov 2022 -
Author:
Soo Romanoff -
Pages:
2
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 Ju ....