If the FDA had concerns about elements of the data then they would typically call an Advisory Committee together to seek advice/clarification around those outstanding inquiries. It seems to me that it speaks to the thoroughness of Acadia's submission, but it most certainly was supported by the work done a couple of months ago with parent forums and the input of the various leading Rett organizations. I can only see this as a very good statement.
Ann: Rett Syndrome NDA accepted for Priority Review by FDA, page-7
-
- There are more pages in this discussion • 157 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 NEU (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
$15.24 |
Change
0.890(6.20%) |
Mkt cap ! $1.927B | |||
| Open | High | Low | Value | Volume |
| $14.35 | $15.27 | $14.35 | $6.555M | 437.5K |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 4 | 1882 | $16.01 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $14.04 | 188 | 1 |
View Market Depth
| Last trade - 15.59pm 27/09/2024 (20 minute delay) ? |
| NEU (ASX) Chart |