Right. I seem to remember a while back with the contrasting agent issue with the FDA, not only was the DeNovo submission the new route, but the contrasting agent now being deemed unsuitable, new regulations were also being established. But maybe I just assumed that part as the whole process seemed to have been reset back to the start almost, and why I have been saying this is a long way from being approved.
Ann: OIL June 2024 Quarterly Report and Appendix 4C, page-6
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