have you looked at the two other trials?
put simply the first two RCTs can be distinguished by the fact they were for early onset aGVHD and a mix of lower and high grade SR-aGVHD.
in totality, remestemcel-l was not statistically more effective against standard of care.
This more recent trial was more weighted to severe cases and that that is where Ryoncil stands out... by a long shot.
But the FDA still can’t see past two failed RCTs, even though they were fundamentally different trials with what MSB purport to be a less potent product.
It defies logic and a pinch of leniency was expected given the high mortality rate.. so that is why so many people got caught out on this one.
In my view it was more likely to get approved than rejected, but I was clearly wrong. But it is now important to take a step back and try see where the FDA’s head is at to figure out how they are likely to act going forward.
- Forums
- ASX - By Stock
- MSB
- MSB to dispute FDA finding in Type A meeting
MSB to dispute FDA finding in Type A meeting, page-221
-
- There are more pages in this discussion • 797 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
(20min delay)
|
|||||
Last
$1.19 |
Change
0.000(0.00%) |
Mkt cap ! $1.370B |
Open | High | Low | Value | Volume |
$1.18 | $1.22 | $1.18 | $2.465M | 2.064M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
11 | 17854 | $1.19 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$1.19 | 12689 | 8 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
4 | 3647 | 1.190 |
16 | 38291 | 1.185 |
11 | 93239 | 1.180 |
12 | 156004 | 1.175 |
8 | 62274 | 1.170 |
Price($) | Vol. | No. |
---|---|---|
1.195 | 33717 | 10 |
1.200 | 73106 | 13 |
1.205 | 43338 | 9 |
1.210 | 136404 | 10 |
1.215 | 3136 | 1 |
Last trade - 11.36am 15/07/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |