Dbv technologies outlines regulatory path for viaskin peanut in children 1 – 3 years after receiving pre-bla responses from fda

Montrouge, france, april 19, 2023 d bv technologies outlin es regulatory path for viaskin peanut in children 1 – 3 years after receiving pre-bla responses from fda the fda confirmed that the company's phase 3 epitope study met the pre-specified criteria for success for the primary endpoint and did not request an additional efficacy study . a dditional safety data will be required to augment the safety data collected from epitope in support of a bla.
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