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banter and General Discussion, page-6894

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Treed

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03/06/23

23:33

Post #: 68117932
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Originally posted by Treed: ↑

Meanwhile the Doc continues quoting trials are from the first decade of the century, with product made by another company that would not meet Mesoblast standards as they are now, based on data they have continued to collect, and delivered to the FDA for the BLA resubmission, and processes they have developed and now demonstrated over 10 days to 4 FDA inspectors during the factory visit.

It seems he was referring to this trial, of prochymal, the only aGVHD trial that included Pediatric patients, Phase 3 placebo controlled;
The dates are;

https://clinicaltrials.gov/ct2/show/NCT00366145?term=mesoblast&cond=aGVHD&phase=2&draw=2&rank=4

That is the trial where it was decided to withdraw all pediatric patients on placebo and redirect them another open treatment system that eventually went on to treat about about 280 children if I recall correctly.

But hang on, I thought he was actually asking about Temcell data?

Anyway back to Temcell, the other paper I linked to is also about the product Temcell (not remestemcel-L, different selection criteria, development made by a different company etc, nor prochymal, older again, as was actually used in the trial you refer to), here's the Abstract, about Temcell, with a little bit highlighted,

From https://www.nature.com/articles/s41409-021-01304-y

Oh, and @iainwoolward I was taught by my tutors that if I had issues with someone else's conclusions or research, do not hold back, that is not appropriate, and that included with regard to tutors, one withdrew. The difference here is ulterior motives are frequently in play here, and I am under no compulsion to be polite, speaking in 3rd person etc. Please do not be naive.

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OK, got my protocol 280 mixed up with the numbers treated, which was actually 260 patients.

From page 23 in https://fda.report/media/141133/ODAC-20200813-MESOBLAST-PPTSlides-PM-SESSION.pdf

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banter and General Discussion, page-6894

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banter and General Discussion, page-6894

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