some would argue that we have a solid chance of approval (albeit nothing is certain), after the FDA said that the data they already have in hand appears to be sufficient to address the concerns of the most recent CRL.
the CRL outlined what the FDA requires before approval, and now the FDA say they think they had what they needed all along.
it’s a very strange thing for the FDA to do a backflip, and they wouldn’t do so unless they were pretty sure they had no other choice. Whatever MSB provided in that type C meeting had to be extremely convincing.
The path of least resistance was to simply say to MSB, “continue as planned, run that adult trial and resubmit”… MSB were all geared up for that… so something quite profound has happened since that has resulted in such a dramatic backflip.
interesting times indeed…
goodluck all
- Forums
- ASX - By Stock
- Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA
some would argue that we have a solid chance of approval (albeit...
-
- There are more pages in this discussion • 254 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
95.0¢ |
Change
-0.005(0.52%) |
Mkt cap ! $1.084B |
Open | High | Low | Value | Volume |
96.0¢ | 98.5¢ | 91.5¢ | $4.743M | 4.999M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
3 | 123302 | 95.0¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
95.5¢ | 314 | 1 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
3 | 123302 | 0.950 |
1 | 23302 | 0.945 |
2 | 43302 | 0.940 |
1 | 20000 | 0.935 |
3 | 80500 | 0.930 |
Price($) | Vol. | No. |
---|---|---|
0.955 | 314 | 1 |
0.960 | 11638 | 7 |
0.965 | 42184 | 5 |
0.970 | 153302 | 6 |
0.975 | 93067 | 6 |
Last trade - 16.10pm 29/08/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |