RE: Wallbrook7 Jul 2020 19:44
"As they say, it is “VERY unlikely” that they would not get the regulatory clearance. I think they are waiting to announce substantial orders upon getting this clearance."
Based on the RNS of May 22nd (extract below) and you will note it does not seem to work like that. They got the CE and THEN distrubuted to potential customers for clinical evaluations. It makes sense doesnt it. Why would anybody bother testing a product if there is a possibility it might not get the local regulatory approval?
"Following CE-IVD marking, the Company can commence commercial sales in the UK and across the EU immediately. The Company will now begin distribution to potential customers for initial clinical evaluations, and aims to record first commercial sales in June. "