Ryoncil - potency assay data, page-2

Hi there,

re your query " But why didn't they include any paragraph about the current inventory being "similar" or "standardised" in the 4C announcement other than the comment that it is "greater.....?"", allow me to redact the actual 4C announcement a little:

Here's the original Bullet Point #1:

" Mesoblast has requested a meeting with FDA this quarter to provide additional potency and characterization data for its product RYONCIL which it believes demonstrate that the product used as second-line after corticosteroids in the pivotal Phase 3 trial GVHD001 in children with SR-aGVHD, which successfully met its primary endpoint of Day 28 Overall Response, was made to a standard supporting the trial as being adequate and well controlled "

and here's the partial redaction (with some underlining added by me for emphasis of a key thread):

" Mesoblast has ... additional potency and characterization data for its product RYONCIL which it believes demonstrate that the product ....., was made to a standard supporting the trial as being adequate and well controlled "

IMO if something is made to a standard then that's 'standardisation/ standardization'. And IMO standardisation which supports a clinical trial is relevant standardisation in the context of an application for marketing approval based on that clinical trial.

It follows that MSB has actually made a statement about it separate from demonstration of the enhanced potencyi.e.

1) that it has new product 'standardisation' data,
2) that they're additional to existing data & relevant to the clinical trial product,
3) that it still wants to deliver & intends delivering those data to the FDA, and
4) that it wants to meet with the FDA this quarter (Q1) & has asked the FDA to do so.

You might ask 'well, why didn't they just use the technical term 'standardised'?' I think it may be because MSB has tried just using proper reference terms in its announcements at various times over the past couple of years, and people complain they just don't understand them. So, they're kind of damned if they do, and damned if they don't.

But, in any case, I don't see this as problematic. Aas I see it there's plenty of other intelligible information in this sentence for holders, and that is plenty of good reason to use the longer-winded expansion of what any degree of demonstrable 'standardisation' can mean for RYONCIL. Hope that assists.

All good, IMO.

Cheers
GLTAH