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Sep 30, 2023
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DBV Technologies Q3 2023 Earnings Report
DBV Technologies received FDA feedback on COMFORT safety studies and reported Q3 2023 financial results.
Key Takeaways
DBV Technologies announced the receipt of written feedback from the FDA regarding the COMFORT supplemental safety studies and reported financial results for Q3 2023. The company's cash and cash equivalents amounted to $149.1 million as of September 30, 2023.
Received written feedback from the FDA clarifying design elements for COMFORT Toddlers and COMFORT Children supplemental safety studies.
Both supplemental safety studies will have harmonized, simplified protocol language on how the product should be used.
COMFORT Toddlers study will apply the same eligibility criteria as EPITOPE, DBV’s Phase 3 efficacy study in toddlers 1-3 years.
DBV anticipates the first subject enrolled in COMFORT Toddlers study in Q1 2024.
Forward Guidance
DBV Technologies expects to submit the final COMFORT Toddlers protocol design to the Agency in the coming weeks and anticipates the first subject will be enrolled in Q1 2024. The initiation of COMFORT Children is expected after the start of COMFORT Toddlers and in alignment with VITESSE recruitment.
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