De Novo Submission Update
FDA identified deficiencies in De Novo submission including clinical validation issues; company initiating supervisory review.
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De Novo update
Oxford, UK. GENinCode Plc (AIM: GENI), the genetics company focused on the prevention of cardiovascular disease, announces an update on its Food and Drug Administration (FDA) De Novo submission. The FDA has provided full feedback on the application and determined that there remains 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 address these elements and is holding ongoing discussions and in-person meetings with the FDA to resolve these deficiencies. 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. The Company will provide a further update at the Preliminary Results at the end of May 2025.
| Walbrook PR Limited | Tel: 020 7933 8780 or |
| Anna Dunphy / Louis Ashe-Jepson / Phillip Marriage | genincode@walbrookpr.com |
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