Ann: PromarkerD clinical assay performance results published, page-13

As with any medical device/test/drug/etc they must pass the regulatory process for each country.

Some hoops already complete for Europe, Italy now on board. First in Europe so number of tests over the next 6-12 mths will be interesting to see.

As per Ann 31 March study in US with partner, “big pharma”, is part of the lead up to FDA approvals. There is no alternative to lengthy studies and validation. Bet your left leg if “big pharma” like what they have before them FDA approval will happen.

Would be near impossible to predict an accurate time line on FDA approval imo.

Once FDA approval is achieved then other global approvals become much easier and even rubber stamp territory. Regulatory approval is one thing, convincing doctors to use it is another matter. A new novel test may take some convincing for many to start using and then we come back to wealth of validation and studies proving its predictive credentials. Egg and chicken.

No quick path to massive commercialisation. I do think as slow as the progress is currently IF “big pharma” get behind it we will see a rapid increase in use in the US. This should then translate to an uptake in other countries imo.