GENinCode Provides Update on FDA De Novo Submission
Why we think this is neutral
This RNS announcement provides an update on GENinCode's FDA De Novo submission, which does not contain any specific financial or operational details that would warrant a stronger sentiment score. The company is working to address outstanding elements identified by the FDA, but the outcome remains uncertain at this stage.
Key Points
- FDA has provided feedback on GENinCode's De Novo submission, identifying outstanding elements that need to be addressed
- Company has initiated a Supervisory Review with the FDA and is holding ongoing discussions to resolve the deficiencies
- Board believes it can address the outstanding elements, but there is no certainty the information provided will be sufficient
- Further update to be provided at the Preliminary Results at the end of May 2025
Summary
GENinCode Plc (AIM: GENI) has provided an update on its Food and Drug Administration (FDA) De Novo submission. The FDA has provided feedback on the application and determined that there are certain outstanding elements, including deficiencies in relation to clinical validation, that need to be addressed. The company has initiated a Supervisory Review with the FDA to resolve these deficiencies and is holding ongoing discussions with the regulator. The Board does not believe that there are any elements that it cannot address, however there can be no certainty that the information provided will be sufficient. A further update will be provided at the Preliminary Results at the end of May 2025.