No issues at the mid cycle review, but just looking at the FDA stages chart, the final stage is approve or issue a CRL.
I was just wondering about the likelihood of FDA approving / issuing a CRL once the enter into that take official action stage?
Seems to me like there’d be no way of a CRL at that stage, but they still list it as an outcome
No issues at the mid cycle review, but just looking at the FDA...
-
- There are more pages in this discussion • 7,306 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 BOT (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
34.0¢ |
Change
0.010(3.03%) |
Mkt cap ! $597.3M | |||
| Open | High | Low | Value | Volume |
| 32.5¢ | 35.0¢ | 32.3¢ | $1.553M | 4.664M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 12 | 191263 | 34.0¢ |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| 34.5¢ | 44058 | 4 |
View Market Depth
| Last trade - 13.00pm 12/08/2024 (20 minute delay) ? |
| BOT (ASX) Chart |