Can you talk about what that means in practice?

The biomarker qualification process really comes down to providing the necessary substantive evidence to, to the FDA that, that gives them the level of confidence that they can rely on the biomarker s- so as a, as a reusable tool, a drug development tool, to be able to have alternative ways of showing that a, a drug is sort of, um, demonstrating sort of tolerable surrogacy and, and, and being able to show treatment effect rel- rel- relative to that, that, that new biomarker.

It's, it's driven by sort of a three-step process, starting with a lever-- letter, letter of intent, which sort of tell, tells us sort of, um, whether biomarker in its context of use are appropriate.

And obviously this part is you have to have a clear use case and wh- and why do we need to do this.

And obviously if it's once accepted there, the question is worth, is it worth pursuing and not endorsement.

Then obviously you go-- one goes towards a qualification plan, and the clinical qualification plan is that's where we sort of generate our roadmap for evidence generation, our anal- analytical validation and our strategy, and to-- and make sure we're having alignment with the FDA on what their expectations are, as well as sort of quantifying sort of stronger evidence, uh, based on the impact the biomarker has.

And then once that's done, we try to put together a package and the, and the-- with all supporting data, as well as all of our clinical ev-ev-evidence, and try to have, have the FDA look at whether it evaluates whether the most important thing is, is, is what we do with them reliable, is the result reproducible, and are the results interpretable.

Can you talk about those a little bit and how they might sort of open the door to exciting and novel trial designs that will be more efficient?