Sareum Holdings plc yesterday announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has given notice that it has not been able to approve the Clinical Trial Authorisation (CTA) to evaluate the safety and tolerability of Sareum’s lead programme SDC-1801. We have published research on this which is attached and a snapshot of the research is below.
The MHRA has indicated that it seeks a further review of the non-clinical data submitted as part of the application to appr ....
09 Nov 2022
Hybridan Research: 09/11/22: Sareum Holdings plc (SAR): Further clarity needed for CTA application non-approval by MHRA for SDC-1801
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Hybridan Research: 09/11/22: Sareum Holdings plc (SAR): Further clarity needed for CTA application non-approval by MHRA for SDC-1801
Sareum Holdings plc (SAR:LON) | 11.0 -0.4 (-24.1%) | Mkt Cap: 7.89m
- Published:
09 Nov 2022 -
Author:
Emily Liu -
Pages:
7
Sareum Holdings plc yesterday announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has given notice that it has not been able to approve the Clinical Trial Authorisation (CTA) to evaluate the safety and tolerability of Sareum’s lead programme SDC-1801. We have published research on this which is attached and a snapshot of the research is below.
The MHRA has indicated that it seeks a further review of the non-clinical data submitted as part of the application to appr ....