Great Work MSB. I am very relieved.
Why do I feel like the acceptance today of the resubmitted BLA which had to address the CRL items is the harder part and the FDA approval is now just an easier formality.
I guess as it’s taken years just to address the CRL items and that was long and hard, I believe the FDA already know REM-L works, it just had to be fully detailed and quantified why it does and how it is safe and consistent.
The approval seems easy from here.
Anyone else feel a bit like that?
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-281
-
- There are more pages in this discussion • 727 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
96.0¢ |
Change
0.025(2.67%) |
Mkt cap ! $1.096B | |||
| Open | High | Low | Value | Volume |
| 95.0¢ | 96.5¢ | 94.0¢ | $1.231M | 1.291M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 4 | 94461 | 95.0¢ |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| 96.0¢ | 61151 | 6 |
View Market Depth
| Last trade - 16.10pm 12/09/2024 (20 minute delay) ? |
| MSB (ASX) Chart |