I know that if we can gain label extension at a time when Paeds aGVHD (Ryoncil) is going through its labelling discussions with the FDA(this year if we get approval) then this is going to be a lot shorter time frame than gaining label extension after another aGVHD Adult trial, Readouts, BLA submission for that and then label extension following if successful.
The question is by which path are MSB proposing. I would have thought by (as you said) use of current Adult EAP data and extension through the Paeds aGVHD labelling would seem to be more in line with accelerated FDA methodologies in place now.
I know that if we can gain label extension at a time when Paeds...
Add MSB (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
$1.09 |
Change
0.015(1.40%) |
Mkt cap ! $1.238B | |||
| Open | High | Low | Value | Volume |
| $1.08 | $1.10 | $1.07 | $2.907M | 2.681M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 15 | 30801 | $1.09 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.10 | 36957 | 17 |
View Market Depth
| Last trade - 14.15pm 21/05/2024 (20 minute delay) ? |
|
|||||
|
Last
$1.09 |
Change
0.015 ( 1.89 %) |
||||
| Open | High | Low | Volume | ||
| $1.09 | $1.10 | $1.07 | 506759 | ||
| Last updated 14.42pm 21/05/2024 ? | |||||
| MSB (ASX) Chart |