FDA noted that the lack of a suitable potency assay for the RYONCIL product used during the
Phase 3 trial MSB-GVHD001 for the pediatric acute GVHD indication has prevented the trial from
being considered an adequate study for the purpose of demonstrating substantial evidence of
effectiveness required for a marketing approval.
Based on the above, if MSB prove it's suitable to FDA requirements, yes to your question.
Ann: Trading Halt, page-637
-
- There are more pages in this discussion • 80 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
94.0¢ |
Change
-0.020(2.08%) |
Mkt cap ! $1.073B | |||
| Open | High | Low | Value | Volume |
| 95.5¢ | 97.0¢ | 93.5¢ | $1.424M | 1.507M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 8 | 29390 | 93.5¢ |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| 94.5¢ | 14089 | 2 |
View Market Depth
| Last trade - 16.10pm 13/09/2024 (20 minute delay) ? |
| MSB (ASX) Chart |