But you were suggesting that we cannot look at the efficacy of mixed doses, being compelling...... why not.
Its a basic principle of science experiments that one should try to keep alternative potential causes, so called other independent variables (which become confounding factors) out of any experiment because if you don't its a lot harder to understand what caused the effect one sees on the dependent variable.
I don't believe I've said one cannot look at the efficacy of mixed doses. It would be a fairer characterisation of my position to say first that its better not to have confounding variables if you can keep them out and second that when looking at the efficacy of doses if you have no choice because that's all you have such as from different production lots (and/or different donors) or from the same donor at different times like when a patient gets a second dose after failing to respond fully to the first, that one needs to recognize that one has introduced possible alternative causes into any observed change. And that that makes it hard to know what main cause was. Sometimes things correlate together because there is a third thing that effects both of them.
The answer is in case 1 donor, or 2 donors' cells do not work, and only 1 or 2 of the 3 donors have cells that actually works.
That sentence is hard to parse because there were Donors 1, 2 and 3 involved in the GVHD001 production lots. The words "Donor 1" "Donor 2" and "Donor 3" literally appear on slide CC-22 they may even be the same three donors. So "in case 1" could be read as "in case one"
If you simply understand that getting the confounding and alternative explanations out of tests is what I am saying the rest becomes a whole lot less complicated. When you absolutely can't get the confounding out - then you have to look at the alternative explanations as well or you are doing bad science.
The FDA said very similar things in their ODAC briefing and transcripts.
Dr Joanne Kurtzberg herself - in her paper Study 275: Updated Expanded Access Program forRemestemcel-L in Steroid-Refractory Acute Graft-versus-HostDisease in Children --- Published in final edited form as:Biol Blood Marrow Transplant. 2020 May - says on page 10
"The possibility that somepatients might have responded to concomitant therapies rather thanremestemcel-L cannot be excluded". I was going to post that to col69 but never sent the post I drafted.
Look at the evidence from the single donor, the mixed donors.... is there a different result?
I can't look with you unless you are more specific about exactly what you want me to look at.
I can show you MSBs own slide CC-22 that has two separate pathways on it that both end up with impacts on CD4 T cells. I've done that already.
Did Bour an Klinker get different results from their 6 lines of lab testing?
Yes. His name is Steven Bauer.
Is the company saying.... only cells from this 1 person, 2 or 3 people actually work?
No.
You are suggesting it's a posibility.... one so great it's worth non approval?
That depends on more things than a question phrased like this can expect a good answer to.
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