(CercleFinance.com) – DBV Technologies announces that it has received written responses from the US Food and Drug Administration (FDA) which clarify the design elements of the COMFORT Toddlers and COMFORT Children additional safety studies.
The biopharmaceutical company will consider the FDA’s comments and plans to submit the final version of the COMFORT Toddlers protocol to the FDA in the coming weeks. It plans to recruit the first patient in the first quarter of 2024.
Furthermore, DBV reports $149.1 million in cash and cash equivalents as of September 30, 2023, a net decrease of $60.1 million over nine months, as well as a net loss of $61.5 million since beginning of the year.