Ann: Annual Financial Results Presentation, page-98

"I am of the opinion that they have data that supports both safety and efficacy,"

You are entitled to your opinion. There are plenty on this forum that have opinions including on efficacy - I've never seen anyone that could put up compelling evidence of efficacy for remestemcel-L as a reproducible product though.

You wanna take a crack?

Here's what I'll grant you - there is longevity data from the Study001 that looks good - better than no treatment and better than a wrong treatment like Rux - which is a jak stat inhibitor - too specific - wrong target.

But to have a reliable reproducible product you need to be able to show that what is in the product that makes it potent is in each product - else its not really the same product.

So here is the problem - MSCs work through a variety of pathways - Silvu's slides aren't wrong about that.

But when you only MSCs from a few donors - three I think, maybe only two (I'd have to go back and check to be sure) then its could be something else in the cells from those donors besides the TNFR1 and IL2Ralpha levels you measured - and if it was the something else that caused the longevity potentially you can't link the longevity results to the potency assay factors you measured alone. You don't actually know you've got the right potency assay until you put the potency assay (without other confounding factors) into patients and see a result in the patients due to those potency assay factors and not others.

That why another trial is necessary in my opinion - they are assuming not demonstrating that the specific potency assay components they have identified as part of their matrix (combination of factors) approach and not something else they neglected to measure in the donated from just two donors (and you can't keep going back to the same donors - they'll get old and they'd run out of bone marrow )- you need to find the potency factors in other donors - so you first need to verify they are the factors to do that - you can measure for the factors if batches if you know them - but you've got to know them.

Only when you demonstrate that your potency assay (A + B (maybe plus C or minus D) actuall produces a good result in new patients can you sure you've got the potency assay right - mining old data doesn't work because it could have been something else that was potent - not the factors you think.

So your evidence for effectiveness? In your opinion? No reply necessary - but that's the problem in a nutshell - MSB hasn't established a causal link between its potency assay and its good results.

IF it had, the science would be clear once it was reported - there wouldn't be all the need for strange and opaque communications. You can't patent strange and vague statements - you have to be specific to get a patent.