Cell Therapy News/Articles, page-16588

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Bazsa

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23/07/23

15:46

Post #: 68933021
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Originally posted by JB1975: ↑

Look closely at the data I just posted. Not going to pretend to understand the science behind the assay, but I do have a grasp of statistics, and those stats look pretty good to me.

That graphic you've posted looks to be a Kaplan-Meier to me. And it looks to consolidate data from two separate MSB protocols (EAP 275 and GVHD001) into a combined data set such that there are 26 (above the median) + 28 (below the median) data points.

I wonder if you'd agree with that much?

I think I do understand the science LED. (I might be able to walk you through it - that would depend, in my opinion, on how much of the science you already do understand, on how willing you are to let me try and also on how much time there is before the 2nd and 3rd August when the FDA is likely to make their decision anyway - based on your comments I think you've a fair bit at stake and are motivated to want to know the truth).

I don't think I'm pretending to understand the science (but perhaps my trying to walk you through it with you being sceptical that I can (because any claim I make about the science you could fact check yourself independently - I have not learned anything except from other sources) might show me I am kidding myself.

I also think I do understand the stats or enough of it.

I currently think (though I could be mistaken - I acknowledge that possibility) that what MSB is doing is presenting the best data they have in the best way they can fashion and present it in order to have the best chance to get the result they want - which is a biologics licence for pediatric sr-GvHD.

I personally don't think that currently they can have enough data to satisfy the FDA's need to have at least one adequate and well controlled trial. But its possible they may have enough - the way they are presenting what they have seems to me that they are hail marying - that is hoping to get a pass from the FDA on safety, on unmet medical need, on some good survivial data etc, without needing to get more data to show that the potency assay they have is really really reliable in ensuring the product is potent.

In my opinion I understand the cell biology side and what is involved in manufacturing cells well enough now that I don't think MSB could be hiding some secret discovery or secret surprise from me. The suggestion frequently made that we are all in the dark together - I will admit (perhaps I am being arrogant or self deluding) I do not believe applies to me.

I think I've learned to much that it can be a desire by MSB to keep some matters commercial in confidence (form others like me - that would include all potential competitors (I'm not a potential competitor - but potential competitors would have analysts that I reckon would know as much as me in my opinion) that they are being vague when they describe what they have. I think they are being vague where their science and stats is weak.

I'm not meaning to boast. What I think I know I've spent a long time learning. And I think most others similarly interested could have learned as well. I am saying is that - commerical confidentiality - can't really keep your trade secrets from people who can understand in small detail (without you telling them anyway) what the ranges of possible solutions are to the problems everyone knows you are dealing with anyway.

What I have written above will seem boastful anyway.

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"And it looks to consolidate data from two separate MSB protocols (EAP 275 and GVHD001) into a combined data set such that there are 26 (above the median) + 28 (below the median) data points."

Could you please give reason to why you think this is consolidated data. Thank you.

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