7th Jul 2025 21:56
GENinCode PLC - Oxford, England-based genetics testing company - Provides update on its US Food and Drug Administration submission for De Novo. "While the number of the outstanding deficiencies has been reduced, the review upheld the FDA's prior view that there remains certain outstanding elements, including further information in relation to clinical validation." The FDA had determined in April that certain outstanding elements in De Novo needed to be addressed, including deficiencies in relation to clinical validation.
Company says: "With the feedback from the supervisory review, the board remains of the view that there is a path forward to provide the further information to resolve these deficiencies to obtain De Novo classification. Discussions with the FDA have been productive with the outstanding deficiencies reducing. 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 has arranged further ongoing clarificatory discussions with the FDA and will provide a further update if this provides additional information."
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By Aidan Lane, Alliance News reporter
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