CYP

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Bazsa

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21/06/24

09:27

Post #: 74419003
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Originally posted by JB1975: ↑

Yep see your post, still working on next part of reply. I'm rereading a lot of old posts and notes - you did some good summaries (I'd forgotten about shark attacks and ice creams) - I wrote a lot of words - I've re-found a few important quotes from Silviu, Fred Grossman, etc...

Your EAP data from November 2023 and February I don't recall - so it might be something.

I was interpreting SI as having essentially said there was no new data just new analysis of old data as recently as 7 March 2024 (s hare ca fe - hidden gems). But new EAP data (though likely to be confounded) is new data of a sort so I do want to look at it.

I think this is the right stuff (patents MSB are trying to get approved relating to potency assay stuff) to be looking at (to see if they can get a BLA) next time.

To recap old research - 11 patients only from GVHD001 got cells each from a single lot. (Silviu talks about a slide at ODAC to that effect). Only three donors were used. (Geraldine Stornton ODAC). Two of those 11 patients show no or very little reduction in T cell activity measured in blood of patients 28 days apart with the first blood being just before first treatment. (me looking at the graphic).

From such a small amount of data points establishing that the survival at 4 and 5 years was specifically due to the TNFR1 levels and IL2Ralpha levels (and not something else in the donor cells that wasn't measured but might be potent) is an important issue.

MSB can't keep using the same three donors - they'll get old, and can't keep donating bone marrow, and cells already taken from them years ago and banked have limited expansion - so to put reliably potent cells into new patients MSB needs to have a potency matrix that can reliably identify potency factors from cells from new donors. Also from their inventory if they want to use it. The cells from the three donors were from Lonza Walkerville not Lonza Singapore (new plant).

I suppose new EAP data might give data from a wider pool of donors than just the first three if new donor derived lots were used.

To be continued..

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Good to see some very good annalise without the personal attacks.

The error.

"To recap old research - 11 patients only from GVHD001 got cells each from a single lot. (Silviu talks about a slide at ODAC to that effect). Only three donors were used. (Geraldine Stornton ODAC). Two of those 11 patients show no or very little reduction in T cell activity measured in blood of patients 28 days apart with the first blood being just before first treatment. (me looking at the graphic"

This statement is at odds to the chart that summaries the data. 11 lots were used in 001. Two lots showed no change in T cells compared to entry levels.

CYP Price at posting: 24.0¢ Sentiment: Buy Disclosure: Not Held
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