Tony
Orphan drug designation eligibility and eligibility for the PRV program are two separate things.
As I said, even though a Priority Review Voucher won’t be on offer for Acadia, this does not mean they can't or won’t get orphan drug designation for NNZ-2591 in Rett or Fragile-X, as you have suggested.
It's like Neuren’s multiple indications for NNZ-2591 – each indication is eligible for orphan drug designation and entitled to the benefits that confers, but only the first indication approved (likely PMS) would be potentially eligible for a Priority Review Voucher, if that scheme is formally extended by US Congress.
My point was that orphan drug designation still offers a drug sponsor significant benefits, even if a Priority Review Voucher isn’t possible.
Tony Orphan drug designation eligibility and eligibility for the...
-
- There are more pages in this discussion • 2 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
$14.05 |
Change
-0.510(3.50%) |
Mkt cap ! $1.795B | |||
| Open | High | Low | Value | Volume |
| $14.38 | $14.42 | $13.94 | $6.419M | 454.6K |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 1 | 500 | $13.99 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $14.07 | 6644 | 4 |
View Market Depth
| Last trade - 16.10pm 04/10/2024 (20 minute delay) ? |
| NEU (ASX) Chart |