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Ann: Mesoblast Resubmits BLA with FDA for Ryoncil Approval, page-128

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Wilba32

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10/07/24

06:27

Post #: 74681565
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Originally posted by JB1975: ↑

Despite the words "potency assay" not appearing in this announcement - let nobody be under the illusion that potency assays are not part - probably the most important part of CMC - Chemistry, Manufacturing and Control. Until very recently, as recent as mid March they were the part concerning Silviu (sh are ca fe video linked elsewhere).

In recently worked upon patent publications MSB agents discussed a "gold standard" in potency assays.

I am not sure that potency assays get measured in terms of gold, silver, bronze standards. I think that may have been poetic license suggesting that sometimes something less than a gold standard will be acceptable in a potency assay when the conditions being treated are of such a serious nature.

Let's just hope the potency assay is better than some toxic-lead-lining-of- the-water pipes so Rome may drink standard but it gets through anyway because Nero's and Caligula's are in charge at the FDA on the current watch. Nothing the FDA have said on their own behalf supports that.

Correlating with IL2Ralpha data from a lot of trials and sorting it arbitrarily into above and below 60% seems exactly like trawling (as DocMcStuffins puts it) to me. It would not have been had that been used only to generate a hypothesis (also as he says in similar contexts) and to then test that hypothesis in adults. But there is no skill or statistical merit in predicting the lotto numbers after the draw. And there is substantial risk in setting good science aside to pander to politics promoted by greed.

On the integrity of a few now cell medicines for many are at issue. Poor products approved may lead to poor patents being granted and a clogging of the therapeutic pipeline with the equivalent of lead-lining.

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Are you referring to Ruxolitnib? RRaGVHD

Are you suggesting poor efficacy? Would you say Rux is an inferior product to REME?

What is the long term survival of children with SRaGVHD that have been treated by Ruxolitnib? I am having trouble locating this data? Apparently, I’m not the only one.

MSB Price at posting: $1.10 Sentiment: Buy Disclosure: Held
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Ann: Mesoblast Resubmits BLA with FDA for Ryoncil Approval, page-128

GreenX picks up prospective copper project in Germany

Vmoto sales plummet -50% YoY as weak demand in Europe & China stifles EV scooter sales growth

Uranium prices on the NYMEX are stable, but ASX uranium stocks are sinking on Friday. The answer lies in Kazakhstan

Week 31 Wrap: JORC rules to get tougher; RBA rate hike chance 50/50; US Fed Sept cut still the quo

Collaboration in a green (steel) future the focus for Magnum and Saudi partners

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Commodity house Trafigura funds Develop Global's copper-zinc Woodlawn play with offtake deal in place

Is oil undervalued?

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Ann: Mesoblast Resubmits BLA with FDA for Ryoncil Approval, page-128

Top Stories

GreenX picks up prospective copper project in Germany

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Uranium prices on the NYMEX are stable, but ASX uranium stocks are sinking on Friday. The answer lies in Kazakhstan

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Commodity house Trafigura funds Develop Global's copper-zinc Woodlawn play with offtake deal in place

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Venture to sniff out high-grade REE targets at Jupiter project, WA

Cost blow-out for Rook I uranium project sees share plummet for NexGen

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