Email extract. Ian Griffiths11 Apr 2022 07:26
This is an extract of an email to Ian Griffiths my question and his response.... well done working Sundays Ian
1. One of the reasons given for ovarian study delays was the challenge obtaining reagent – are you able to add any information to this i/ is it now available ii/ how much reagent is needed for the study – is it a small amount?
"Yes, unfortunately, our supplier did not meet its scheduled delivery of certain reagents as capacity was sequestered by US government for fulfilment of COVID test kits, but this has now been received and analysis is progressing."
2. We are going down the FDA approval route – as parsortix is CE marked already and has been for 10 years is there any reason why we are not applying in parallel to the UK and EU. Surely that would reduce risk and reliance on one approval and ensure eggs aren’t in one basket – unless of course Angle are extremely confident in the FDA approval
"FDA clearance is the gold standard worldwide and the US is the largest market by value and hence our primary focus. The existing CE Mark approach in Europe is “basic” and self-certified so does not carry the credibility that the FDA clearance does (the EU recognises this and the rules are changing this year). Nevertheless, the CE Mark provides helpful background information on Parsortix and has helped with sales to translational researchers, but it does not detail specific use of the instrument for allowing downstream analysis which is required for commercial adoption. The data provided for FDA clearance was also designed to provide the necessary package required to self-certificate in Europe for the same intended use in metastatic breast cancer, and we will make this self-certification once FDA clearance has been granted."
Great updates and feels positive