DBV: lifting of the partial clinical suspension by the FDA – 23/12/2022 at 09:55


(CercleFinance.com) – DBV Technologies announces that the US FDA has lifted the partial clinical suspension of its phase 3 VITESSE clinical trial which will evaluate the modified Viaskin Peanut 250 μg patch (DBV712) ​​in children aged four to seven years.

The FDA has confirmed that DBV has satisfactorily addressed the issues raised in its clinical hold letter. The updated protocol will be submitted to the clinical sites for subsequent approval by the Human Protection Committees and Ethics Committees.

The company expects to begin the patient selection process in the first quarter of 2023, with the last to be selected in the first half of 2024, and expects the publication of the first results of the VITESSE study for the first half of 2025.



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