Regulatory hiccup
RUA Life Sciences have announced a regulatory update on the 510(k) submission for its vascular graft products that was filed on November 3rd, 2021. The FDA appears to have questions about the products that will almost certainly take longer to resolve than the normal review window. RUA and the FDA have converted the application into a pre-notification process and RUA does not now expect its first commercial sales in the first quarter of 2022.We are leaving our valuation unchanged at £122.9m or 554p per share despite the delay to the 510(k) process for the vascular graft products since RUA are still in an, albeit longer regulatory process with the FDA, which should result in the approval of those products.
We are making no changes to our financial forecasts ahead of RUA’s interim results.
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