Don't try to read anything into it - it is just the way it is done, and for good reason.
MSB is well aware of the potential issues from their ongoing discussions with the agency, so no question of going in blind. Their submission specifically seeks to address those issues.
Don't forget, the panel is not the FDA - they will not be aware of all the discussions between the sponsor and the agency - they need to be brought up to speed, and in particular on what points the FDA wants their expert opinion.
It is not a question of giving the sponsor additional time - because if these issues are determined to be substantive, it will take a long time for the sponsor to rectify them (eg additional trial - don't forget the FDA normally requires two Phase 3 studies - we are hoping the EAP will be accepted as one of those studies, but there is no guarantee of that).
- Forums
- ASX - By Stock
- MSB
- MSB Trading - Aug 2020 on
MSB Trading - Aug 2020 on, page-1369
-
-
- There are more pages in this discussion • 1,016 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 | $2.446M | 2.047M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
12 | 10544 | $1.19 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$1.20 | 27409 | 10 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
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 - 11.31am 15/07/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |