Ann: Investor Presentation, page-571

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pfeifer1982

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24/06/24

18:14

Post #: 74465497
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Originally posted by JB1975: ↑

How could the investigating team go from 54 patients and censor that group down to just eleven that just happened to be 1 patient per lot used in 001? The chances of this ? 1 in a million.

I sort of expect you to change the subject rather than be persuaded. But how could they is easy.

They had to drop from 54 back to 51 because three of patients got old product - so under MSBs own argument it wasn't relevant.

Looking specifically at seeing how IL2Ralpha inhibition was correlated with changes in T cells activation in patients blood 28 days after treatment - we'll they could only do that if the patients blood was taken and recording allowing them to do that - and that only occurred in the case of 25 patients. The investigating team simply couldn't compare with blood from patient readings of the 54 that didn't exist to be compared with. I don't know why only 25 patients had serum levels (taken), I just know that that was reported as what as what was available - had they had 26 or 27 it would have been better to use all they had - bigger data set better stats - but they didn't so they used the 25 they had. Its that simple.

Once you realise relevant blood measurements were only available for 25 of the 51, then that 25 gets cut down even further by an investigation team because you can't correlated IL2Ralpha levels with T cells in blood levels when you bundle two separate lots together because that would make no sense. Any patient getting treated for the first time would have had their T cell levels measured for day zero, then they got lot 1 from donor 1, didn't completely recover, so got lot 2 from perhaps the same donor of perhaps another - but as soon as you introduce that second lot into the same patient - then you are no able to see the effect of only the first lot on that patients T cell levels after 28 days - you introduced a variable - and you won't be able to tell if the exact patient had got only the second lot the first time - if that alone would have fixed them.

So its only the patients that got treated by only one lot that can tell you anything about how that lot impacted the T cells levels in that patient.

So the investigators had no choice but to cut out of the 25 all those that got multiple lots.

So that's my process of getting down to nearly 11 - the only other things I add are a comment from Silviu and some logic about numbers being grouped (ie when you are dealing with small numbers - a person culd actually try dropping say 14 or 15 into the graphic you've seen - assuming the dots were effectively double dots if you want - and then see if it changes the stats if you allocate your 14 or 15 to the 11 visisble dots.

Now that my process - your process ?

The chances of this ? 1 in a million.
Sounds like you come up with a remarkably round number (1 in a million) on the basis of nothing at all that I can see.

Expand

You:
"Looking specifically at seeing how IL2Ralpha inhibition was correlated with changes in T cells activation in patients blood 28 days after treatment - we'll they could only do that if the patients blood was taken and recording allowing them to do that - and that only occurred in the case of 25 patients."

I don't believe that statement is correct:
"Results: Biomarker data were collected in 40 subjects. At baseline, the mean age was 8.5 years, aGVHD severity by IBMTR grade C or D, median MAP was 0.369, with a MAP ≥ 0.291 in 60% of subjects, reflecting active gastrointestinal inflammation and high risk for 6-month NRM."
https://ash.confex.com/ash/2020/webprogram/Paper140899.html

25 patients or as I understood the 60% of the 40 patients (24, but 62.5% seemed close enough to me) of these subjects with a MAP ≥ 0.291, were then matched with "27 closely matched children from the Mount Sinai Acute GVHD International Consortium (MAGIC)2 who participated in a prospective natural history study" to show the survival benefit of the patient group treated with remestemcel-L vs SoC.
https://www.globenewswire.com/news-release/2021/10/18/2315632/0/en/Remestemcel-L-Improves-Survival-of-Children-With-Biomarkers-for-Highest-Mortality-in-Steroid-Refractory-Acute-GVHD.html

Or is the above simply coincidence (genuine question)?

Last edited by pfeifer1982: 24/06/24

CYP Price at posting: 27.0¢ Sentiment: Hold Disclosure: Held
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