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$23.22 neuren pharmaceuticals limited

Acadia, page-11

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Vapor

1,374 Posts.

284

19/07/22

09:43

Post #: 62601571
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Originally posted by mpec: ↑

Wait what? The way I read this, is that the FDA can issue another Voucher?

Trofinetide has been granted Fast Track Status and Orphan Drug Designation for the treatment of Rett syndrome in the United States. An NDA with Orphan Drug Designation is eligible for priority review. Trofinetide has also been granted Rare Pediatric Disease (RPD) designation by the FDA. With such designation, Acadia expects to be awarded a Priority Review Voucher if the NDA is approved.

Why would they type "to be awareded a Priority Review Voucher"? I thought they already have one for Trofinetide?

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We got the RPD designation which provides the potential to be awarded the voucher upon NDA approval.

The orphan drug designation gets us a priority review anyway so therefore 6 month review from acceptance.

Last edited by Vapor: 19/07/22

NEU Price at posting: $3.91 Sentiment: Buy Disclosure: Held
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(20min delay)
Last $23.22		Change -0.750(3.13%)		Mkt cap ! $3.032B

Open	High	Low	Value	Volume
$23.93	$23.97	$23.05	$9.512M	403.2K

Buyers (Bids)

No.	Vol.	Price($)
8	476	$23.21

Sellers (Offers)

Price($)	Vol.	No.
$23.22	260	7

View Market Depth

No.	Vol.	Price($)
6	154	23.170
4	257	23.160
11	2702	23.150
2	181	23.140
3	204	23.130

Price($)	Vol.	No.
23.190	251	7
23.200	948	3
23.210	202	4
23.220	308	5
23.230	230	3

Last trade - 12.09pm 28/05/2024 (20 minute delay)


Last $23.33			Change -0.750 ( 2.66 %)
Open	High		Low	Volume
$23.81	$23.94		$23.07	84616
Last updated 12.30pm 28/05/2024 ?

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