The original BLA included data on 309 kids across three trials
This resubmission is laser focused on the phase lll with 54 patients which met the primary endpoint.
Subsequent independent data on 51 of those patients after 4 years show 49 % survival - my word- Cured
No control patients survived at 4 years.
Control patients used best available therapies including Ruxolitinib.
Ruxolitinib is approved in SR a GvHD for over 12 years of age, it does not improve long term survival
If Mesoblast's first product Ryoncil is approved for pediatric use then label extension into SR adults who do not respond to Ruxolitinib seems likely.
Add in label extension to Chronic GvHD , depending on pricing, we may get close to a double digit share price.
Two weeks for acceptance/non acceptance notification - USA 22nd July- Melbourne 23rd July
Potential PDUFA dates
Class 1 USA Monday 9th September - Melbourne Tuesday 10th September
Class 2 USA Thursday 9th January 2025 - Melbourne Friday 10th January
Acceptance is likely because the document has been accepted twice before and has only been improved since.
If we get a Class 1 it would be time to get excited
If we got a Class 2 then it would likely receive a much earlier PDUFA date as todays announcement referred only to the remaining CMC issues. Guessing no later than end of October 2024.
GLTALTH's
Reg
The original BLA included data on 309 kids across three...
-
- There are more pages in this discussion • 218 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Add MSB (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
$1.28 |
Change
-0.030(2.29%) |
Mkt cap ! $1.461B | |||
| Open | High | Low | Value | Volume |
| $1.32 | $1.35 | $1.28 | $1.677M | 1.289M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 10 | 44452 | $1.28 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.29 | 23596 | 1 |
View Market Depth
| Last trade - 16.10pm 04/11/2024 (20 minute delay) ? |
| MSB (ASX) Chart |