You clearly have not read all of the company announcements and listened to the presentations.
They have said very explicitly that FDA informed them that a path to an EUA for Covid ARDS requires another trial and that OTAT approving the Remestemcel-l CMCs is required before starting that trial. Yes, the OTAT meeting is about the GVHD BLA, but they are very clear that the results of that meeting would allow them to proceed with the ARDS trial in addition to allowing resubmission of the GVHD BLA.
Also, they have said that the data from the first ARDS trial is being used to support their claims with OTAT. Similar MOA in both indications means potency assays relevant for both.
OTAT Meeting, page-21
-
- There are more pages in this discussion • 16 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
$1.17 |
Change
-0.025(2.10%) |
Mkt cap ! $1.330B | |||
| Open | High | Low | Value | Volume |
| $1.18 | $1.22 | $1.15 | $6.344M | 5.404M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 1 | 8683 | $1.16 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.17 | 32999 | 1 |
View Market Depth
| Last trade - 16.10pm 15/07/2024 (20 minute delay) ? |
| MSB (ASX) Chart |