RE: Approvals?21 Sep 2023 19:24
The next steps are to finalise standard production and operating protocols and to commence clinical trials that should lead to an accredited Laboratory Developed
(LDT) test for launch initially in the USA. The Company will then extend that to other key markets and will extend its use through regulatory approval with the FDA in the USA, the EMA for a CE mark in Europe, the MHRA in the UK for UKCA approval, and with the appropriate regulatory groups elsewhere in the world including China.
Cizzle Biotechnology will continue to own all intellectual property rights and, through its further funding of research programmes at the University of York, aims to create new solutions for early cancer diagnostics and develop new therapeutics.
Looks like they have nailed it to me