Ryoncil - potency assay data, page-4

First 4 Last

Share
Profile

Follow
Blackkkkkkk

1,125 Posts.

216

06/02/24

13:42

Post #: 72262768
Share

Originally posted by Phaedrus: ↑

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

Expand

Thanks for sharing these thoughts.
Agree that there is plenty of reason and information to remain hopeful about MSB, but the fact that we've been here many times before is what is prompting me question whether they've actually got all of their bases covered this round.
Been a holder since 2020 so the pain is subtle now but I'd be damned if this round with the FDA does not bear any fruit.

MSB Price at posting: 26.0¢ Sentiment: None Disclosure: Held
3 Upvote

0 Great analysis

Reply

Top Stories

Listen: HotCopper Wire Podcast 018 – Potatoes, TACOs, and the $120M helicopter heist

HotCopper Highlights: Trigg; Droneshield; Lumos & more

DRO

History repeats for DroneShield investors but carnage so far subdued

PSC

Prospect's Mumbezhi Project puts it at the middle of copper's megatrend. And FQM just bought in

STN

Saturn brings up seventh straight Apollo Hill upgrade on 'impressive' 300-hole drill run

First 4 Last

Add to My Watchlist

What is My Watchlist?

A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.

(20min delay)
Last $2.43		Change 0.640(35.8%)		Mkt cap ! $3.020B

Open	High	Low	Value	Volume
$1.90	$2.46	$1.90	$39.76M	17.85M

Buyers (Bids)

No.	Vol.	Price($)
20	55828	$2.43

Sellers (Offers)

Price($)	Vol.	No.
$2.44	36575	17

View Market Depth

No.	Vol.	Price($)
5	5879	2.440
16	93039	2.430
16	262779	2.420
15	59184	2.410
47	68207	2.400

Price($)	Vol.	No.
2.450	51121	9
2.460	131732	11
2.470	114965	11
2.480	320350	11
2.490	84443	17

Last trade - 13.15pm 18/07/2025 (20 minute delay)

MSB (ASX) Chart

Ryoncil - potency assay data, page-4

Listen: HotCopper Wire Podcast 018 – Potatoes, TACOs, and the $120M helicopter heist

HotCopper Highlights: Trigg; Droneshield; Lumos & more

History repeats for DroneShield investors but carnage so far subdued

Prospect's Mumbezhi Project puts it at the middle of copper's megatrend. And FQM just bought in

Saturn brings up seventh straight Apollo Hill upgrade on 'impressive' 300-hole drill run

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

Ryoncil - potency assay data, page-4

Top Stories

Listen: HotCopper Wire Podcast 018 – Potatoes, TACOs, and the $120M helicopter heist

HotCopper Highlights: Trigg; Droneshield; Lumos & more

History repeats for DroneShield investors but carnage so far subdued

Prospect's Mumbezhi Project puts it at the middle of copper's megatrend. And FQM just bought in

Saturn brings up seventh straight Apollo Hill upgrade on 'impressive' 300-hole drill run

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News