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$1.07 mesoblast limited

What Data is available from Japan?, page-42

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Fastback6666

1,892 Posts.

646

08/08/23

22:00

Post #: 69233223
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Originally posted by dachopper: ↑

Great job finding out the Temcell data, however I think your message has missed the mark slightly.

Remestemcel-L has had the potency assay changed over time, and it is not the same as Prochymal.
It is a different product, and Prochymal had different characteristcs to Remestemcel'L.

If you have a look at the ODAC briefing material 2020.
Remestemcel_L, has TNFR1 average 260 - 340 pg/ml, and
% IL2 Inhibition of around 80%, which is no where near the temcell release criterea.

You can see both are no where near the Prochymal release criterea of 105 and 30%, and infact, in the ODAC this was pointed out several times that the assays have been tightened and the results are better because of this.

https://public4.pagefreezer.com/browse/FDA/04-03-2022T19:30/https://www.fda.gov/media/140996/download

They may once have been comparable, but are not comparable any more.The new potency assay was only just presented in Feb 2023 !
In effect , fix the assay, then do another trial.
The assay data only came out in Feb 2023, and now 6 months later we are doing another trial?

Could that process have occurred any faster? I don't think so.

Expand

Yeah good point.

MSB Price at posting: 37.5¢ Sentiment: Buy Disclosure: Held
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