This is what I think happened,
MSB provided the potency and product data for the trial, which had an issue with it.
During the last 2 years, the purpose of the IL2Ralpha assay changed.
Possibly minimum acceptable levels for the assays also changed.
The FDA now want proof that all the current inventory has met the same potency standards that the manufactured product for the GVHD001 trial did.
That could involve additional release testing of batches ( If the IL2 potency assay did chance ),
or possibly just gathering the data of the release testing that was allready performed.
Mesoblast CC Transcript 31/8, page-32
-
- There are more pages in this discussion • 42 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
$1.49 |
Change
0.140(10.4%) |
Mkt cap ! $1.701B | |||
| Open | High | Low | Value | Volume |
| $1.37 | $1.54 | $1.37 | $23.10M | 15.82M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 3 | 24758 | $1.49 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.49 | 73626 | 3 |
View Market Depth
| Last trade - 16.10pm 04/10/2024 (20 minute delay) ? |
| MSB (ASX) Chart |