I understand those words from Mesoblast pretty much the same as...

I understand those words from Mesoblast pretty much the same as I imagine that you do.

I'm typing it out again as I read it (whilst logged in) - I can't read excerpts unless I login and I want to be able to see the exact words without having to do so again.

"Mesoblast also intends to provide FDA with additional potency assay data for RYONCIL product manufactured using the current FDA-inspected process, linking product which was used in the pediatric Phase 3 trial, which met its primary endpoint, with product which will be used in the proposedregistration Phase 3 trial in adults.Showing that the product used in the pediatric and adult trials is standardized, together with data showing that the future product is well characterized for commercial release, could support approval for the pediatric indication given the absence of an approved therapies for children".

I am reading all of that - carefully crafted language (ie "intends", "FDA-inspected process" "linking" "met its primary endpoint", "could" (sic) ) - as being MSB's corporate opinion. Presumably with the language of an announcement having been skim read or more likely closely and carefully read by Silviu himself so as to not being legally dangerous to the company.

I note they don't refer to the pediatric trial as the pivotal trial in those sentences (but they do say, technically correctly - it met its endpoint. A pivotal trial, as I understand is the trial that is the one providing the evidence that pivots a product from not yet approvable to approvable.

I would expect a successful adult trial to be a pivotal trial for both adults and pediatrics. But it won't be unless it is given the go ahead, and goes ahead,(recruiting is not always possible for trials - not for the numbers - sometimes trials can't recruit enough patients - this was something that affected the trials for GVHD in Europe - the RETRIM trials I believe they were named) and succeeds.

ASIDE - for some reason the hotcopper reporting says you tagged me and that stellowe tagged me - but you didn;t and he didn't - it seems that if a post is replied to that has a tag, an @ character in it, as Irenes did, then the next post effectively re-tags.

I don't mind, its just quirky.

BTW. It is my understanding that blood samples taken from patients - like for instance the blood samples that would have been taken from pediatric patients in the GVHD trial described to ODAC in 2020 would not normally be cryopreserved.

It did occur to me that if the entire contents of a blood sample could be reliable frozen with some sort of snap freezing then you could in theory have a sort of time capsule of what was going on immune system wise in the blood of a patient at a particular now long past time point.

I don't have specialist knowledge of that - I'd have to research it, but my intuition is that things like cytokines in blood would not survive freezing and rethawing and that it is likely therefore that blood from patients would not routinely be indefinitely retained.

If you are a medical doctor you might off the top of your head have some knowledge about that. Do you?