If the resubmission is incomplete:
1. Ensure the designation in the regulatory system is corrected to
“Incomplete Response to CR letter” if the review team confirms that the
submission did not address all issues identified in the CR letter
CRL one questioned multiple issues including efficacy
CRL questioned ,imo, two issues- potency assay of trial product- potency of product to be sold if marketing approval given.
FDA saying go ahead and refile , one could consider that issues identified had been addressed-
I like our chances
Reg- been wrong twice
- Forums
- ASX - By Stock
- 2024 Here we go again.
If the resubmission is incomplete:1. Ensure the designation in...
-
- There are more pages in this discussion • 113 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
$1.42 |
Change
-0.045(3.07%) |
Mkt cap ! $1.581B |
Open | High | Low | Value | Volume |
$1.45 | $1.46 | $1.37 | $5.177M | 3.686M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
16 | 10842 | $1.42 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$1.42 | 3817 | 5 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
16 | 16484 | 1.420 |
12 | 28891 | 1.415 |
8 | 21774 | 1.410 |
6 | 32578 | 1.405 |
8 | 156826 | 1.400 |
Price($) | Vol. | No. |
---|---|---|
1.425 | 22490 | 13 |
1.430 | 82358 | 10 |
1.435 | 137787 | 8 |
1.440 | 18302 | 6 |
1.445 | 144410 | 4 |
Last trade - 12.50pm 09/10/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |
The Watchlist
AHK
ARK MINES LIMITED
Ben Emery, Executive Director
Ben Emery
Executive Director
SPONSORED BY The Market Online