When you say "at the time of ODAC that was all the data MSB represented on the
data,"
I didn't say data (
yellow) I said slide (I rechecked my own post) - referring specifically to slide CC-32 presented by Mesoblast at ODAC.
I respect the effort you are making (I can see you must have read other posts to answer Bazsa as you did recently and see that phaedrus had gone to wikipedia) and the time you are taking. But I think its important we understand what each of us is actually saying.
given that it is in my opinion a very broad statement, but what I actually said (slide - as in CC-32 specifically) made my focus very tight and my statement very specific
All the data they had analysed at the time?No
not Magic biomarker data (based on ST2 and Reg3alpha readings) - not any of the other data (from other trials) or any of the other hypotheses (where they would try to bring that sort of data into some sort of argument for a BLA) - none of that is what I am referring too here.
Only all the data they had from trial MSB-GVHD001 (not other trials) and only data relating to single donor lots and only data that specifically correlated X with Y where X was the inhibition of IL2alpha and Y was decrease in T cell activation over 28 days. And only at ODAC as in at the time of ODAC. That's all I'm referring to there.
I could post the transcript of Silviu speaking about slide CC-32 right next to a slide-32 if it would help (that is actually how I see those things - I did that ages ago and made screenshots and printed the screenshots and added my own commentary to the screenshots which was base evidence) that how I work when I am trying to be accurate - because the FDA doesn't have the ODAC era slides and transcripts on site anymore I'd have to go to the wayback machine and recreate for you the data - if you won't look at it yourself using my page references. I'm willing to do that but - really I'd said slide not data.
All I was asking you was don't you think its reasonable that Silviu had all the data from single donor lots on his slide cc-32 that that was available at that time?
Its a yes or no question - in my opinion - I was going to go on from that as a next step by you've misread me.
The only relevant data that could be placed on a slide headed "Remestemcel-L bioactivity In Vivo is Study 001: Inhibition of IL-2Ralpha Expression In Vitro is Associated With In Vivo reduction of Activated CD4+ T Cells" - is data that was from Study 001 and could be plotted X versus Y where X is I'm quoting off slide CC-32 "% IL-2Ralpha inhibition in vitro" and Y (the vertical axis) is "%change in CD3+CD4_CD25+HLD-DR+ (baseline to Day 28)".
Now Bazsa has suggested behind each of the 11 data points there might be more than one patient because MSB may have averaged them - so far as I can understand what he is saying he must be saying for instance there might be several patients who received a single lot of say 82% inhibition of IL-2Ralpha and rather than plot them separately with their own readings for % change in T cell activity - MSB bunched them together and averaged the several to get a single dot point.
The link that I pasted from MSB mentions specifically "Emergency Investigational New Drug (EIND) protocol from 2015-2023" (https://investorsmedia.mesoblast.com/static-files/adfc1ba0-bd4d-47bd-b0a0-a0b3516b0520). If its not from Study001 it can't be used to correlated In vitro with in vivo measurements in patients in trial 1. You are mixing up two different lines of inquiry. You are assuming I think I'm done with my point and moving onto yours (you might have a separate point (about other data not to do with Study001) - I am open to that *separately*- but it isn't relevant to this one).
Once they got the FDA presumably to agree on that point,No that's question begging!
I just needed a yes or no answer on the specific question - I didn't need it in a hurry, you needed to understand it and to request clarification if you didn't understand it - which you have done. But its still that question (yes or no) I wanted the answer to. Because if like Bazsa you think there may be multiple data points behind the eleven dots I know I need to deal with that.
I can hold competing hypotheses in my head - I can consider that MSB possibly with the assistance of patient advocacy groups appealing to the emotions of Peter Marks or someone senior in the FDA might possibly manage to get them to drop the standards of evidence that is required down below a standard of evidence that someone like Steve Bauer (departed) and Matt Klinker (still there I understand) might want the FDA to do. That's politically and psycholiogcally possible. The FDA could end up with a person like Joanne Kurtzberg on the inside - feeling the patients pain and the advocacy groups pain in front of them - and forgetting the bigger picture of all the pain of those not in front of them if the science standards are allowed to drop to far.
To my mind it is possible that Silviu has gotten a response from an FDA that has changed (its deteriorated) - thats possible. It will be disappointing if that has happened. It will be bad for medicine if that has happened - but its possible.
But that is separate to - is the science solid enough in itself. If the science is solid enough in itself you don't need a weak or deteriorated FDA - the science should be good enough to provide substantial evidence even to the Klinkers and the Bauers and the folk like me that need to see objective science not an emotional appeal.
My question to you is still about the science - I don't care what you think MSB thinks so much as what you think about the science - hence my concentration on the science (the yes or no question)- its a given that the FDA might make a bad decision (though they haven't done that yet in this case - we only have MSB's accounts of what the FDA have supposedly said to them to know what the FDA have said beyond ODAC).
(20min delay)