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I’m pretty sure they have 2 months to accept the NDA, so 18...

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moloch

747 Posts.

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19/07/22

13:51

Post #: 62608717
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Originally posted by fyffee ↑

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.

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I’m pretty sure they have 2 months to accept the NDA, so 18 September is our deadline.

NEU Price at posting: $4.17 Sentiment: Buy Disclosure: Held
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(20min delay)
Last $18.71		Change -0.760(3.90%)		Mkt cap ! $2.387B

Open	High	Low	Value	Volume
$19.49	$19.56	$18.60	$6.929M	367.0K

Buyers (Bids)

No.	Vol.	Price($)
4	12	$18.70

Sellers (Offers)

Price($)	Vol.	No.
$18.72	281	6

View Market Depth

No.	Vol.	Price($)
4	239	18.670
9	425	18.660
5	240	18.650
5	1924	18.640
6	1843	18.630

Price($)	Vol.	No.
18.690	126	3
18.700	468	4
18.710	271	3
18.720	454	7
18.730	231	2

Last trade - 14.30pm 11/06/2024 (20 minute delay)


Last $18.70			Change -0.760 ( 3.99 %)
Open	High		Low	Volume
$19.44	$19.55		$18.60	115243
Last updated 14.49pm 11/06/2024 ?

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