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BioWorld - Monday, May 25, 2026
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Home » Adhering to its guns, DBV seeks meeting with FDA on CRL for peanut allergy patch
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Adhering to its guns, DBV seeks meeting with FDA on CRL for peanut allergy patch

Aug. 4, 2020
By Randy Osborne
The matter of how adhesion of its Viaskin Peanut allergy patch relates to efficacy became a major problem for DBV Technologies SA, which drew a complete response letter (CRL) for the once-daily epicutaneous (EPIT) product. Shares of the Montrouge, France-based firm (NASDAQ:DBVT) closed Aug. 4 at $2.34, down $1.76, or 43%, in reaction to the CRL for the patch, designed to protect children ages 4 to 11. The FDA wants DBV to modify the patch, which means a new human-factor study; officials also are requiring clinical data for the modified patch.
BioWorld Medical technology Regulatory Combination drug-device Immune FDA

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