FDA Approval23 Feb 2022 17:29
Having reviewed details regarding the submission, posted via RNS since early 2019, it is clear that the company has been on ongoing dialogue with FDA and has done an excellent job with due diligence, in order to minimise the risk. Secondly they have pressed on with Lab services based on the presentations, which are already generating revenue. I would assume (Like RENX) that they don’t actually need FDA approval to be successful, but the whole process would happen a lot faster and with greater confidence.