RE: Genedrive Plc. The most important RNS>>>20 Oct 2024 07:31
Just to be clear, the De Novo process for FDA approval of MT-RNR1 test has NOT yet begun. I’ve had it confirmed in an email from the company. They are gathering data and hope to finally submit early 2025. With special device designation and potentially quicker approval times this means there is a chance it could be approved by Easter 2025 but GDR needs to know for sure that it will not run out of funds as it goes through the process which could take as little as three months.
The next news GDR might receive is either on UK sales of either test, and EU and ME test of the AIHL test OR a green light from the impact assessments being concluded at the end of this month for the NHSS. That is now just 11 market days away. That’s why there has been recent interest here. If CYP2C19 is used for not only stroke victims but also cardiac arrest victims then NHSS along could provide approx £1m annual revenue for GDR. If that green light is given then England will have to follow suit pronto. At the moment NHS England is dragging its heels but once Scotland employs the tests then that would open up the NHs to legal challenges if fictions realise the test is available but hasn’t been used and they have the CYP2C19 gene and suffer adverse reactions from the standard application of the drug Clopideogel.
Oct 31st is a very very big day for GDR