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Exactly. The FDA will look at any newly "generated data" with...

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whytee

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09/01/24

13:09

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Originally posted by JB1975 ↑

I see all your excerpts - but Mesoblast are just playing games with words in my opinion. And they are doing that to buy time to solve money problems in my opinion - they are keeping all science references abstracted away - no mention of the content of the potency assays or of how scientifically or procedurally they will proceed.

Formerly, before the second CRL I could see ways to make sense of MSBs obscure references and to give them the benefit of some doubt - I can't do that any longer - there isn't sufficient scientific and procedural uncertainty - that is clear enough (ie it is clear enough what their matrix approach to potency assays was at the time of GVHD001 (Tnfr1 and IL2ra levels) and its also clear they had INFg swinging around in their batches - Infgamma being once called macrophage activating factor (and all MSBs summaries show activated macrophages (M1 and M2 states freom memory) are NOT what is wanted in an enviroment of GvHD.

What MSB says in the paragraph that the "FDA notes" is not the same as what they "Intends to generate in the coming months" in the very next paragraph which you've excerpted.

There aren't that many potential actors (things like TNFR1, Il2ralpha, INfgamma etc) and there aren;t that many patients in the GVHD001 trial (blood taken from them after they were treated was blood taken at a particular time point - there is no time machines). You can associate molecules in blood with levels of molecules in a treatment of course (statistically associate) - but you can't get a cause and effect relationship by trying to retrospectively put the horse in front of the cart.

GVHD001 patients had their treatments - that is done - to associate potency assay matrix values with new patients and so show mechanism of action you need to have new patients (you can't do it with the old ones) - thats the point of the adult trial. If they can get it going.

But unless the potency assays are produced reliably and consistently it won't even matter - garbage in (release assays all over the place (different reagents, different antibodies etc) will give garbage out - (confounding variables).

MSB simply needs to take a new plausible potency assay to new patients and show the cause and effect relationship between contents of the new potency assay in the new patients.

SI, in my opinion, is just running funders around the block with obscure language as he buys time. Scientifically what he is saying lacks specificity - but what he can actually do is not infinite - science limits what he can do. Stats limits what he can do.

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Exactly. The FDA will look at any newly "generated data" with bemusement and recommend they do a new randomised controlled clinical trial in adults and or children using the potency assay and biomarkers to track response...

Last edited by whytee: 09/01/24

MSB Price at posting: 29.0¢ Sentiment: Sell Disclosure: Not Held
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