Following discussions with the FDA relating to RUA's recently submitted 510(k) application for its range of vascular graft products, it has been agreed that the filing will be converted to a pre submission process. This change will extend the regulatory pathway and as such RUA no longer anticipates generating first commercial sales during FY22. Clearly this is disappointing news for the company; however, our forecasts do not include vascular graft sales and therefore this update does not impact ....
13 Dec 2021
Cenkos: RUA Life Sciences Plc - Vascular graft update
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Cenkos: RUA Life Sciences Plc - Vascular graft update
RUA Life Sciences Plc (RUA:LON) | 8.8 0 (-3.3%) | Mkt Cap: 5.49m
- Published:
13 Dec 2021 -
Author:
Chris Donnellan -
Pages:
7
Following discussions with the FDA relating to RUA's recently submitted 510(k) application for its range of vascular graft products, it has been agreed that the filing will be converted to a pre submission process. This change will extend the regulatory pathway and as such RUA no longer anticipates generating first commercial sales during FY22. Clearly this is disappointing news for the company; however, our forecasts do not include vascular graft sales and therefore this update does not impact ....