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GENinCode UK Ltd. ( (GB:GENI) ) has provided an announcement.
GENinCode Plc announced an update on its FDA De Novo submission, revealing that while the number of outstanding deficiencies has decreased, further information related to clinical validation is still required. The company remains optimistic about addressing these deficiencies through ongoing discussions with the FDA, although there is no certainty that the information provided will be sufficient for approval.
More about GENinCode UK Ltd.
GENinCode Plc is a UK-based company specializing in genetic risk assessment for cardiovascular disease, which is the leading cause of death and disability worldwide. The company operates in the UK, Europe, and the United States, offering predictive technology that combines clinical algorithms and bioinformatics to provide advanced patient risk assessment for cardiovascular disease.
Average Trading Volume: 624,684
Technical Sentiment Signal: Sell
Current Market Cap: £6.45M
Find detailed analytics on GENI stock on TipRanks’ Stock Analysis page.