InvestorsHub Logo
Boards
News
Market Data
Markets
Discover
Discover
AI Subscribe Login/Register account icon
S&P 500
5,983.99
(
-0.29%
)
US TECH 100
20,517.20
(
-0.18%
)
Dow Jones
43,910.98
(
-0.86%
)
Brent Oil
71.63
(
-0.27%
)
Bitcoin
88,181.09
(
-0.65%
)
Post# of 430335
Next 10
Reply Private New
Public Reply Private Reply New Post
Keep Last Read
Keep Next 10 Report Keyboard Shortcuts
Next 10 Prev Next

Biobillionair

Send PM Follow Ignore
Followers 233
Posts 26887
Boards Moderated 0
Alias Born 01/12/2013

Biobillionair

Re: None

Thursday, 08/15/2013 3:16:01 PM

Thursday, August 15, 2013 3:16:01 PM

Post# of 430335
Dr. Woodcock your words will come back to haunt you...LOL!!!

http://www.regulations.gov/#!documentDetail;D=FDA-2013-P-0025-0003

Read pages 5 and 6, Janet explains how the FDA does it...

Background:
-Vascepa has no exclusivity after a year
-NDA letter had no reason why an Ad Com wasn't required
-The drug this letter is refering to is a mix that's already been approved before.

Must Read and then laugh.... a lot!

Williams

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

Avant Technologies and Ainnova Tech Form Joint Venture to Advance Early Disease Detection Using Artificial Intelligence • AVAI • Nov 12, 2024 9:00 AM

Swifty Global Announces Launch of Swifty Sports IE, Expanding Sports Betting and Casino Services in the Irish Market • DRCR • Nov 12, 2024 9:00 AM

Oohvie App Update Enhances Women's Health with Telemedicine and Online Scheduling • HLYK • Nov 11, 2024 8:00 AM

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

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

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

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