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2023 The Final Countdown, page-3306

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dachopper

4,191 Posts.

5464

07/09/23

01:39

Post #: 69762127
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Originally posted by JB1975: ↑

So, if you got this far, well done. The non holders probably haven'tOne of them did at least.

You've laid out what seems to be a pretty fair timeline of MSB announcements. And you've said they are facts - I'm fine with accepting they are facts about what MSB said.

But with some more science understanding you could supplement you timeline analysis with some other facts. Knowing what is scientifically possible would help you with that. For instance understanding how assays are done. How antibodies are used. How peripheral blood mononuclear cells are used.

Understanding that it doesn't matter if you have 25 patients that got product - you can't reliably associate the effect multiple batches of the product - you need to have single batches in single patients to be able to confidently ascribe the patients performance to batch 1 (the only batch they got) - if they got two batches perhaps the second batch was potent and the first wasn't - and the same patient might have responded to just the second had they got that first.

I submit you need to understand the difference between a biomarker of the disease condition (blood readings - measuring ST2 and Reg3alpha) and biomarkers of putative product effectiveness in the patient before and after treatment being comparative levels of IL2Ralpha expression (CD25) expression on samples of T-cells (likely helper T cells) in the blood at two time points (before treatment) and after treatment (say 28 days).

But you also need a basis for confidence that the blood samples which you are using to survery the types of blood cells at the before treatment and after treatment (28days) timepoints are actually measuring just the T cells you want to inhibit - not good inhibition regulatory T cells (they were probably helping ward off GvHD you want them working hard - what you don't want activated is the helper T cells. So you measure the blood from the patient at two time points. You specifically measure it for is changed level in IL2Ralpha - but how do you show the FDA that that in itself a good enough in vitro and in vivo correlation to prove causation. How can you be sure the IL2Ralpha readings aren't tangling up Reg T cell and Helper T cell - well the answer is you might know some science - you might be able to rule out some things if you do or at least identify that where there is confounding remaining a new process - perhaps a lab process done on retained samples of the lots used to treat patients if they still exist - or perhaps a new process involving new lots into new patients.

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Well done for reading it. 1 upvote to make your day

What you said is fine in theory, but at the end of the day the FDA are happy with the efficacy as it has been demonstrated so there is no need to ponder over such items any more.

No, I really don't need to understand that level of detail. My decision is simply to invest or not. I am not running the trials or sending mesoblast suggestions.

I look at the level of detail that I need to decide are the cells having an effect, and do I think they will get approved. They are the only two questions I look to answer

MSB Price at posting: 46.0¢ Sentiment: Buy Disclosure: Held
22 Upvote

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2023 The Final Countdown, page-3306

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Enova Mining unveils "high-grade" REE drill hits at Coda North, Brazil

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Week 37 Wrap: HotCopper likes Cuban oil; markets shrug debate off for Putin; firebrand quant says social media a market threat

Antipa divests its Citadel interest to JV partner Rio for A$17M, refocuses on Minyari Dome

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2023 The Final Countdown, page-3306

Top Stories

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Metals Australia kicking off plant study at Lac Carheil; Canadian tariff tailwind potential

Vulcan appoints investment bank and M&A veteran to board

Mako sniffs gold at 170 g/t at Cote d’Ivoire's Napié play

Dale Gillham's weekly wrap: US fracking support boosts outlook for Australian gas stocks

Week 37 Wrap: HotCopper likes Cuban oil; markets shrug debate off for Putin; firebrand quant says social media a market threat

Antipa divests its Citadel interest to JV partner Rio for A$17M, refocuses on Minyari Dome

Olam Agri raises Namoi takeover offer to 75 cents a share and receives shareholder backing

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