I posted this on the thread regarding CRLs written by Husch Blackwell LLP.
https://mondaq.com/pdf/clients/371622.pdf
On page 8 under “Responding to a Complete Response Letter,” you can respond to the FDA in 3 ways. Resubmit an application, withdraw an application or request a hearing. The hearing described does not seem to be the same as a “type A” meeting. Does this mean if MSB’s request for a type A meeting is rejected or the accelerated approval is rejected, they can fall back on one of the 3 response options listed above.
It doesn’t seem that requesting a type A meeting falls under one of the listed responses to a CRL. I’m assuming MSB will respond to the CRL as well as requesting the type A meeting?
- Forums
- ASX - By Stock
- MSB
- MSB to dispute FDA finding in Type A meeting
MSB to dispute FDA finding in Type A meeting, page-397
-
- There are more pages in this discussion • 621 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
$1.16 |
Change
-0.035(2.94%) |
Mkt cap ! $1.370B |
Open | High | Low | Value | Volume |
$1.18 | $1.22 | $1.15 | $4.016M | 3.400M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
17 | 34292 | $1.16 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$1.16 | 27287 | 5 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
7 | 23629 | 1.155 |
15 | 87177 | 1.150 |
14 | 115134 | 1.145 |
14 | 237750 | 1.140 |
7 | 139822 | 1.135 |
Price($) | Vol. | No. |
---|---|---|
1.160 | 42202 | 9 |
1.165 | 66862 | 10 |
1.170 | 95234 | 10 |
1.175 | 6888 | 2 |
1.180 | 45423 | 7 |
Last trade - 13.02pm 15/07/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |