A timing question of FDA response and the PDUFA date that has been bugging me.
In the past it has taken the FDA/MSB nearly two months to respond and to the BLA submission and announce the PDUFA date. That is noted from past posts by Reg I believe.
Soooo…..
If the review time needed by the FDA is only 2 months for this BLA submission - are the FDA simply going to respond after nearly two months and say approved rather than issue a PDUFA date!
or are the FDA going to change their PDUFA timing response to MSB to be a lesser time this time around, like after 3 weeks a response from the FDA to set a 2 Month time frame.
If 6 months obviously situation is just repeated like last two times - that is known.
Interested to know thoughts on timings on FDA/MSB announcements for 2 month review.
- Forums
- ASX - By Stock
- MSB
- Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-864
-
-
- There are more pages in this discussion • 233 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Add MSB (ASX) to my watchlist
|
|||||
Last
97.0¢ |
Change
-0.005(0.51%) |
Mkt cap ! $1.107B |
Open | High | Low | Value | Volume |
98.5¢ | 98.5¢ | 96.0¢ | $2.168M | 2.226M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
1 | 16000 | 96.5¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
97.0¢ | 86854 | 7 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
1 | 16000 | 0.965 |
1 | 23000 | 0.960 |
4 | 56273 | 0.955 |
5 | 46225 | 0.950 |
2 | 65500 | 0.945 |
Price($) | Vol. | No. |
---|---|---|
0.970 | 50000 | 2 |
0.975 | 20000 | 1 |
0.980 | 894 | 1 |
0.985 | 48122 | 2 |
0.990 | 54328 | 5 |
Last trade - 16.10pm 23/08/2024 (20 minute delay) ? |
MSB (ASX) Chart |
The Watchlist
SER
STRATEGIC ENERGY RESOURCES LIMITED
David DeTata, Managing Director
David DeTata
Managing Director
SPONSORED BY The Market Online