DBV Technologies : Worst-case scenario
>Request for a new trial on humans - DBV has just received a complete response letter from the FDA ahead of its review of the biologics licence application (BLA) which was initially anticipated for tomorrow. This stipulates that the FDA cannot approve Viaskin Peanut on the basis of the elements that have so far been provided by the company. The FDA’s main questions concern the impact of local adhesion of the patch relative to its efficacy. The FDA has also requested ...DBV Technologies is a clinical-stage specialty biopharmaceutical company focused on immunotherapy. Co.'s therapeutic approach is based on epicutaneous immunotherapy (EPIT), its proprietary method of delivering biologically active compounds to immune systems through intact skin using a platform called Viaskin. Viaskin is an electrostatic patch that offers a self-administered, non-invasive immunotherapy to patients. Once applied on intact skin, Viaskin forms a condensation chamber that hydrates the skin and solubilizes the antigen, allowing it to penetrate the epidermis, where it's captured by Langerhans cells. Co.'s patients include infants and children suffering from severe food allergies.
Oddo Securities provides securities brokerage and research services. The company offers equity, economic, and derivatives research and credit analysis services. It focuses on insurance, automotive, building materials, pharmaceuticals, telecommunications, information technology, and agri-food industries.
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