Sorry thought I answered this - my reply seems not to have gone through.
The FDA is key performance indicated against the number of BLAs and BLA resubmissions it manages to do in a a period of a year or so - it has to report on those. This means it has to project manage so as to give itself the best chance to achieve a 6 month response time once it has accepted a resubmission for review.
Booking and sending inspectors to Singapore would be something necessary to do unless it was already clear the BLA resubmission was going to fail. Presupposing failure - before taking a good look at all the details of the submission would be wrong - so booking and doing an inspection is just necessary to try to ensure the FDA can give a response in 6 months as its supposed to do.
Reviewing all the info in BLA resubmission critically and fairly is a big project - it has to be handled with critical path analysis for the FDA to meet its time commitments - that why in my opinion.
- Forums
- ASX - By Stock
- MSB
- Ann: Trading Halt
Ann: Trading Halt, page-244
-
- There are more pages in this discussion • 1,107 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
99.0¢ |
Change
0.010(1.02%) |
Mkt cap ! $1.130B |
Open | High | Low | Value | Volume |
99.5¢ | $1.02 | 98.5¢ | $5.507M | 5.501M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
1 | 9996 | 99.0¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
99.5¢ | 18069 | 3 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
1 | 9996 | 0.990 |
2 | 32880 | 0.985 |
4 | 71034 | 0.980 |
2 | 3059 | 0.975 |
7 | 145890 | 0.970 |
Price($) | Vol. | No. |
---|---|---|
0.995 | 1132 | 1 |
1.000 | 9500 | 3 |
1.005 | 35000 | 1 |
1.010 | 58113 | 4 |
1.015 | 46100 | 3 |
Last trade - 16.10pm 28/06/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |
The Watchlist
LU7
LITHIUM UNIVERSE LIMITED
Alex Hanly, CEO
Alex Hanly
CEO
SPONSORED BY The Market Online