InvestorsHub Logo
Boards
News
Market Data
Markets
Discover
Discover
AI Subscribe Login/Register account icon
S&P 500
5,973.10
(
0.00%
)
US TECH 100
20,508.40
(
-0.16%
)
Dow Jones
43,729.34
(
0.00%
)
Brent Oil
74.52
(
-1.25%
)
Bitcoin
76,141.34
(
0.32%
)
Post# of 473493
Next 10
Reply Private New
Public Reply Private Reply New Post
Keep Last Read
Replies (1) Keep Next 10 Report Keyboard Shortcuts
Replies (1) Next 10 Prev Next

Steady_T

Send PM Follow Ignore
Followers 167
Posts 20402
Boards Moderated 3
Alias Born 12/09/2004

Steady_T

Member Level

Re: mrplmer post# 427859

Thursday, 09/07/2023 4:24:20 PM

Thursday, September 07, 2023 4:24:20 PM

Post# of 473493
Accelerated Approval does not mean the approval process for an NDA is any faster than the regular approval process. It means that surrogate endpoints can be used in place of efficacy endpoints that might takes years to complete.

The only way to get a faster approval process is Fast Track or Priority designations. That shortens the approval time frame from the usual 10 months to 6 months.
Pediatric Rett has Fast Track designation. AD does not.


Biogen's AA was 10 months after the NDA was submitted.

BOREDOM, It's a terrible thing to waste.

Public Reply Private Reply New Post
Keep Last Read
Replies (1) Keep Last Read Next 10 Report Keyboard Shortcuts
Replies (1) Next 10 Prev Next
Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Detailed Quote
Recent AVXL News
More AVXL News
InvestorsHub NewsWire

FEATURED DBG Pays Off $1.3 Million in Convertible Notes, which Retires All of the Company's Convertible Notes • Nov 7, 2024 2:16 PM

FEATURED SMX and FinGo Enter Into Collaboration Mandate to Develop a Joint 'Physical to Digital' Platform Service • Nov 7, 2024 8:48 AM

SANUWAVE Announces Record Quarterly Revenues:  Q3 FY2024 Financial Results • SNWV • Nov 8, 2024 7:07 AM

Rainmaker Worldwide Inc. (OTC: RAKR) Announces Successful Implementation of 1.6 Million Liter Per Day Wastewater Treatment Project in Iraq • RAKR • Nov 7, 2024 8:30 AM

SBC Medical Group Holdings and MEDIROM Healthcare Technologies Announce Business Alliance • SBC • Nov 7, 2024 7:00 AM

VAYK Confirms Insider Buying at Open Market • VAYK • Nov 5, 2024 10:40 AM

Start posting your company's news
Only $200 per official company press release!