GENinCode Provides Update on FDA De Novo Submission

Why we think this is neutral

The RNS announcement provides an update on GENinCode's FDA De Novo submission, which is not one of the mandatory news types required for a more detailed analysis. While the update indicates some progress in resolving outstanding deficiencies, there remains uncertainty around the final outcome.

Key Points

FDA provided feedback on GENinCode's De Novo submission
Number of outstanding deficiencies reduced, but certain elements still need to be addressed
Company believes it can provide the required information, but no certainty of success

Summary

The genetics company focused on cardiovascular disease prevention provides an update on its FDA De Novo submission, indicating progress but remaining uncertainty.

GENinCode Plc (AIM: GENI) has provided an update on its Food and Drug Administration (FDA) De Novo submission. The company received feedback from the FDA on its previous assessment, with the number of outstanding deficiencies reduced. However, the FDA review upheld its prior view that certain outstanding elements, including further information on clinical validation, still need to be addressed. The company remains optimistic about a path forward to provide the additional information required to obtain De Novo classification, but there is no certainty that the information provided will be sufficient.

CLINICAL TRIAL UPDATE