NEU neuren pharmaceuticals limited

Ann: Acadia submits Rett Syndrome New Drug Application to the FDA, page-17

  1. 1,361 Posts.
    lightbulb Created with Sketch. 353
    So Acadia have submitted the New Drug Application, and it's up to the FDA to accept it for evaluation. How long does the FDA normally take to confirm it has accepted the application to be evaluated, given we have fast track status and orphan drug designation for trofinetide. And then how long would the FDA take in its assessment before Acadia receives approval to begin producing the drug for commercial sales. I hope these processes happen at better than glacial speeds, especially given the unique status this drug has and the demand from families with children who have this terrible disorder.
 
Add to My Watchlist
What is My Watchlist?
A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.
(20min delay)
Last
$14.20
Change
0.890(6.69%)
Mkt cap ! $1.761B
Open High Low Value Volume
$13.50 $14.26 $12.96 $9.111M 655.8K

Buyers (Bids)

No. Vol. Price($)
1 2000 $14.17
 

Sellers (Offers)

Price($) Vol. No.
$14.23 3278 1
View Market Depth
Last trade - 16.15pm 27/06/2025 (20 minute delay) ?
NEU (ASX) Chart
arrow-down-2 Created with Sketch. arrow-down-2 Created with Sketch.