I want to add a small note here - that document I obtained is a patent application publication. It hasn't been granted yet in the United States or anywhere that I've so far found.
The claims including claim 1 are still potentially up for final approval by the examiner. It is possible to take the words and diagrams on their face though.
In the patent application though there are matters that clearly relate to the potency assay. And indicate MSBs thoughts.
I am still working through - I may not have much more time to spend on this - but I noticed this diagram as part of figure 7 in the drawings of the patent application because I had seen it before in MSBs ODAC material and because the number and pattern of the dots say something that I think is important about the number of patients - it goes to the N value. There are only 11 of them and they are the same in both diagrams. Though the p value is different.
Here is the figure from the ODAC materials - so its what MSB offered back in August 2020.
See bottom left "dots represent individual lots". That's MSB note on their slide.
I still think that is all the data that MSB has that relates to IL2Ralpha as a component of the potency assay matrix from 001 - and I think it is still not enough.
Elsewhere in the patent application, figure 6, is a Kaplan Meiier showing survival probability and it has two lines one for IL2Ralpha greater than 60% and one for IL@Ralpha less than 60% - but the number of patients/subjects tracked on that diagram from day 0 is 316 plus 124 for a total of 440.
That diagram I assume (to get 440) is a composite of patients from a lot more trials than 001 and so it integrates trial data both before and after the talked about at ODAC change in the protocol.
In my opinion.
I am very well aware that that is way more forensic than almost anyone here will follow - but it is the data. And I think it, along with other stuff in the patent application, it shows what MSB are likely to argue and present - its still a two part matrix of TNFR1 and IL2Ralpha.
(20min delay)