banter and General Discussion, page-10256

"Perhaps it was the best they could come up with in the months before ODAC is 2020. But there has been years since then and its still the same data (that's why I've put the two figures side by side) they are using in an attempt in 2024 to get a patent related to IL2Ralpha inhibition."

This data is been generated by the old potency assay, yet the FDA rejected BLA 1 on the grounds that the new potency assay had inconsistent outcomes for patients. So this chart has no input to BLA 1 outcome. FDA may have even rejected that data as it was for the old potency assay. They reviewed the new potency assay. The data is very significant as it shows that 001 product was standardised to the standard of the old potency assay. No lot allowed patients to progress. This is why BLA 2 was rejected.

JB
"And when as anyone with about mid high school maths in Australia from memory could see that has plotted some x's and y's onto a graph - its the same data in both cases. Its not necessary to understand all the details to see that its the same pattern of 11 spread around a space and the labels are the same AND YET MSB treat the same data differently and produce different statistics underneath."

As would be expected . Both significant, more detailed information and you now cast doubt to MSBs motives to include a new annalise in a patent application.

JB
"Had MSB wanted to strengthen the case they thought they were making at ODAC they could perhaps have added new data from EAP patients IF they'd been able to get EAP patients that didn't take another drug between first treatment with remestemcel-l (when blood could be taken) and 28 days later. That would be new data - that could then add that to the old data and it would be more. Of course the new EAP patients wouldn't be part of the Study001 which produced the longevity but it would further show a relationship between IL2Ralpha lots with say more than than 60% inhibition reduction also potentially reducing T cell activation levels in new patients."

And who is to say they haven't. Of course there would be many confounding factors that would be ridiculed by a few here.

JB
"Because the thing is it might have been completely incidental - the IL2Ralpha inhibition levels - when there are only three donors involved - something else in the batches from those three donors might be responsible for the reduction in T cell activation levels - but new batches from new donors (because its done to test the hypothesis that its an IL2Ralpha inhibition level of more than 60% - not to just trawl it up) make it less and less likely that it was donor specific characteristics other than IL2Ralpha inhibition that mattered "

Given that this data comes from a pre existing potency assay it is indeed the validation of the potency assay that you have demanded . "something else " covered as a quality attribute not as a potency assay.

JB
"As I type these sentences I know some of this stuff isn't clear and a typo can make a statement very wrong. But the concepts are less complicated than people think. And the more people that do try to think and don't just attack each other for profit the better will be both the medicines we get and the policies."

True, that is why you and whytee have failed the pub test. You have even admitted censoring 20 that should not have been in your annalise.