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LearningEachDay

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13/05/24

01:53

Post #: 73788334
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Originally posted by whytee: ↑

Nope I did't. Survival rates are pretty variable depending in which study you read. SI likes to say "mortality as high as 90%" but that's cherry picking extreme data. And other treatments have survival ranges that overlap with that quoted for Remestemcel. But in the two previous controlled blinded phase 3 trials they couldn't achieve the primary end point of improvement in survival over standard of care despite promising results in the phase 2 trial. Now SI wants to convince the FDA that a trial that is no better quality than the Osiris phase 2 trials qualifies as sufficient evidence for approval. I don't believe it does.

I also think that the potency asssay they have decided to use doesn't qualify as "validated". I notice SI seems to have dropped that claim now. But the potency assays for mesenchymal stem cells have been a subject of controversy and debate for years. No-one as far as I know has yet managed to show that the potency assay they have been using correlates well with clinical outcomes. Mesoblast isn't the only company that produces mesenchymal stem cells and does trials, and some of them try to derive them from multiple donors as a way to reduce the varaiblity in clinical effect from single donor lines.

For those reasons along with others, I'm expecting the FDA to ask Mesoblast to do another trial.

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Yes YT, keep pretending that Prochymal and Remestemcel are the same product. I know how much that fallacy suits your agenda.

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Pick Today's Price Range Low-High... Just for Fun, page-431

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