With Peanut Patch in FDA Purgatory, DBV Plans Layoffs to Stretch Cash
Summary
But on Friday the company, which is headquartered in the southern outskirts of Paris, said it would start layoffs and scale down its drug development activities to save cash in case the radio silence it says it has received from the agency since it submitted additional data in April indicates further delays to come. Late that year DBV withdrew the application after regulators indicated it needed to provide more information about its manufacturing procedures and quality controls. The biotech, which has North American operations in Summit, NJ and New York, says it replied in April with data analyses showing the patch sticks to the skin long enough each day for most patients to experience clinical benefit. The plan is intended to give the company flexibility to continue operations if the review process is extended or handle commercialization if Viaskin is approved. DBV is also studying Viaskin in a Phase 3 trial for toddlers ages 1 to 3, and reported that both doses being tested appear to be well tolerated, and after one year, providing treatment benefit.
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