My interpretation is that the FDA are not convinced the disease is different in children vs adults.
Rux (current standard of care) is not offered to children on safety concerns, not lack of efficacy.
This is something the FDA has obviously made an internal decision on. That is why the FDA briefing notes were so important and was the red flag we all decided to overlook due to an overwhelming ODAC decision. Me included.
this will complicate their accelerated approval submission IMO.
- Forums
- ASX - By Stock
- MSB
- MSB to dispute FDA finding in Type A meeting
MSB to dispute FDA finding in Type A meeting, page-213
-
- There are more pages in this discussion • 805 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add MSB (ASX) to my watchlist
|
|||||
Last
$1.19 |
Change
0.085(7.69%) |
Mkt cap ! $1.358B |
Open | High | Low | Value | Volume |
$1.10 | $1.20 | $1.09 | $13.21M | 11.37M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
1 | 15000 | $1.19 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$1.19 | 75212 | 5 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
1 | 15000 | 1.185 |
1 | 20000 | 1.175 |
1 | 5664 | 1.170 |
1 | 17568 | 1.160 |
3 | 56695 | 1.150 |
Price($) | Vol. | No. |
---|---|---|
1.190 | 59712 | 2 |
1.195 | 36255 | 5 |
1.200 | 404381 | 31 |
1.205 | 3000 | 1 |
1.210 | 162475 | 7 |
Last trade - 16.10pm 12/07/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |