EuGeni, page-2317

so we heard last Wednesday

"The European Clinical Trial currently underway is also evaluating the updated multiple-use claim, to enable this to be included in the EU Common List registration application."

not just common list but also TGA and FDA. speaking of FDA, it was a surprise that "AnteoTech completed analytical and clinical performance evaluations in the US and the UK respectively, that focussed on validating the test’s effectiveness in detecting the Omicron variant of SARS-CoV-2," so we have done some work in the US.

from the last quarterly

"During the quarter, a significant amount of work was undertaken to prepare the clinical protocols and screen trial sites across Europe. The final site selection and site visits, a key step in the clinical trial process, have now been completed. At the time of writing, ethics protocols for each site were under review by the individual study sites and the CRO."

so we will using more than 1 site, unlike the Melbourne trial which was only run at the Alfred hospital.

from the jan quarterly

"Currently, manufacturers of COVID-19 RATs who wish to be included on the EU Common list require sponsorship by an EU member state and a full European based prospective clinical trial including 100 positive samples and 200 negative samples, achieving a sensitivity of 80% or above and specificity of 98% or above."

"We will fulfil this requirement by running a clinical trial in Spain via the Spanish clinical research organisation AKRN."

so only 300 samples to be collected from multiple sites. the trial has started before last Wednesday. we have AKRN doing the preparation.

https://akrnconsulting.com

and we have our new experienced regulatory affairs consultant to oversee the planning and execution of the trial. she has a lot of experience including over 5 years with Abbot. (you know the company that Ian worked at before joining Anteotech).

https://www.linkedin.com/in/fiona-gould-fkgconsultancy/

so I have an idea of how long the Alfred trial ran for with exactly the same sample requirements 100 +ve and 200 -ve. with our European clinical trial having already started it will be interesting to see how long it will take seeing they are using multiple sites.

it will be exciting if we get TGA, FDA and common list approval and any type of battery deal within the next few months. add an announcement of a new CEO and European sales in the next quarterly "Following several distributor meetings focused on identifying market segments outside the EU Common List requirement in Europe, AnteoTech’s distributors have secured a number of initial orders for delivery in April, positioning EuGeni in the European market."

2022 the year of ADO.