"we've provided all the data to the FDA and we think more than meets their, um, their criteria."
I think ppl are struggling to put together the sequence of events and outcomes.
This interview was done obviously before FDA gave their recent feedback resulting in the rushed announcement last week, without waiting for the minutes of the meeting. So the new assay data SI refers was already provided to the FDA. Their decision to accept the GVHD-001 is likely a result of this new data.
Now why would this new assay information, probably highly IP sensitive, be available in the public domain?
I think as Stockrock has pointed out, the announcement being put out prior to FDA minutes being provided in 30 days, the usual mesoblast practice, is to ensure a fully informed market to highly price sensitive news. Was it price sensitive or a bit of puff? Maybe ask SP to see if has an opinion on the matter.
- Forums
- ASX - By Stock
- Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA
"we've provided all the data to the FDA and we think more than...
- There are more pages in this discussion • 76 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
$1.13 |
Change
0.050(4.65%) |
Mkt cap ! $1.284B |
Open | High | Low | Value | Volume |
$1.08 | $1.13 | $1.07 | $5.964M | 5.444M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
1 | 25000 | $1.11 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$1.13 | 176236 | 7 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
1 | 25000 | 1.110 |
2 | 149752 | 1.100 |
1 | 16932 | 1.095 |
1 | 16932 | 1.090 |
1 | 16932 | 1.085 |
Price($) | Vol. | No. |
---|---|---|
1.130 | 176236 | 7 |
1.135 | 72500 | 2 |
1.140 | 41258 | 4 |
1.145 | 14746 | 2 |
1.150 | 18885 | 5 |
Last trade - 16.10pm 21/05/2024 (20 minute delay) ? |
|
|||||
Last
$1.12 |
  |
Change
0.050 ( 4.69 %) |
|||
Open | High | Low | Volume | ||
$1.09 | $1.13 | $1.07 | 829227 | ||
Last updated 15.59pm 21/05/2024 ? |
Featured News
MSB (ASX) Chart |
The Watchlist
AUQ
ALARA RESOURCES LIMITED
Stephen Gethin, Non-Executive Director & Chairman
Stephen Gethin
Non-Executive Director & Chairman
Previous Video
Next Video
SPONSORED BY The Market Online