GVHD the first step, page-78

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dachopper

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20/12/22

14:22

Post #: 65383746
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Originally posted by JB1975: ↑

I don't think MSB can have generated enough data to satisfy the FDA/CBER that they have a potency assay predictive of product performance yet based on the information they've put into the public domain.

If you check out my post on MSB slides where INF-gamma handling is on them but not involving the TNFR1 expression potency assay -you see why I've got doubts still - still to much confounding variability - both TNFalpha through the TNFR1 receptor and INFgamma through IDO (different paths/routes) can affect T cell proliferation (ie can inhibit it).

And in-vitro T cell proliferation inhibition is being taken as the indicator/ surrogate of survival.

MSB have claimed they are using the same potency assay not new ones and if they did use new ones the data from the trials would needs to be associated/correlated with the new potency assays.

The longevity data is good but based on product from only three donors. The MAP, MBS stuff, ST2, Reg3alpha seems like good biomarker stuff.

The EAP data gives MSB other donor lots (some 11 I think you pointed out in a post to me) which is better than just the three in GVHD001 (the 54 patients) but those 11 had confounding variables.

The problem I see for MSB is that Klinker and Bauer understand potency really quite well. They are probably,in my opinion amongst the best qualified (by their experimental work) experts in the area. They are not going to get conned or snowed and they've resisted pressure - the ODAC vote would have been a sort of political pressure.

In my opinion MSB is close - I reckon the cell probably do work - did work in the 54 patient trial and did produce good longevity results - but those were only from three donors. The FDA will need to be confident future product from other donors will also be potent - and I don't think what MSB has been able to do so far is enough to show that.

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I guess your doubt is understandable given you have no clue what msb submitted in the IND update, and are basing your opinion on 2 year old data plus speculation.

MSB Price at posting: 92.0¢ Sentiment: Buy Disclosure: Held
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