It is clear in the announcement
"Prior to implementation, the clinical trial protocol will be reviewed by two independent National Heart, Lung, and Blood Institute (NHLBI)-appointed committees. Mesoblast will then submit the final protocol to FDA, as agreed at the Type A meeting with FDA in September."
Then it goes on to state "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 proposed registration Phase 3 trial in adults. Showing that the product used in the pediatric and adult trials is standardized, together with data showing that future product is well characterized for commercial release, could support approval for the paediatric indication, given the absence of any approve therapies for children.
So there could still be approval for RYONCIL in paeds prior to the completion of the adult trial.
- Forums
- ASX - By Stock
- Ann: Mesoblast Partners with BMT CTN on Adult SR-aGVHD Trial
It is clear in the announcement "Prior to implementation, the...
- There are more pages in this discussion • 325 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add MSB (ASX) to my watchlist
(20min delay)
|
|||||
Last
$1.16 |
Change
0.070(6.45%) |
Mkt cap ! $1.318B |
Open | High | Low | Value | Volume |
$1.12 | $1.20 | $1.11 | $20.88M | 17.94M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
5 | 59978 | $1.15 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$1.16 | 34019 | 3 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
5 | 59978 | 1.150 |
9 | 317014 | 1.145 |
2 | 42121 | 1.140 |
8 | 119942 | 1.130 |
4 | 55950 | 1.125 |
Price($) | Vol. | No. |
---|---|---|
1.155 | 25519 | 2 |
1.160 | 51465 | 2 |
1.165 | 57384 | 5 |
1.170 | 62000 | 4 |
1.180 | 14000 | 1 |
Last trade - 16.10pm 06/05/2024 (20 minute delay) ? |
|
|||||
Last
$1.15 |
  |
Change
0.070 ( 5.63 %) |
|||
Open | High | Low | Volume | ||
$1.12 | $1.20 | $1.12 | 3733217 | ||
Last updated 15.59pm 06/05/2024 ? |
Featured News
MSB (ASX) Chart |
The Watchlist
LU7
LITHIUM UNIVERSE LIMITED
Alex Hanly, CEO
Alex Hanly
CEO
Previous Video
Next Video
SPONSORED BY The Market Online