I don’t think it is on the grounds of efficacy or safety. Rather on manufacturing.
This could be a relatively quick fix, I mean there are two types of CRLs.
Type 1 (minor) is a 2 month review time by the FDA. And a Type 2 is a 6 month review time.
So if MSB get a CRL recommending some minor manufacturing changes, and they go and fix it in a couple of weeks... then they submit the reports / data to the FDA and they have 2 months to approve or issue another CRL.
if it’s deemed a major submission (type 2), then the FDA have 6 months to review it.
Ann: Trading Halt, page-559
-
- There are more pages in this discussion • 77 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
 (20min delay)
|
|||||
|
Last
$1.02 |
Change
0.015(1.49%) |
Mkt cap ! $1.164B | |||
| Open | High | Low | Value | Volume |
| $1.00 | $1.04 | 94.0¢ | $11.76M | 11.90M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 6 | 206912 | $1.02 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.03 | 37637 | 1 |
View Market Depth
| Last trade - 16.10pm 31/07/2024 (20 minute delay) ? |
| MSB (ASX) Chart |