InvestorsHub Logo
Followers 6
Posts 1087
Boards Moderated 0
Alias Born 07/18/2006

Re: tiv111 post# 5059

Wednesday, 08/02/2017 3:56:55 PM

Wednesday, August 02, 2017 3:56:55 PM

Post# of 17454
Fast Track drugs can be approved after a single Phase 2.

"Then, in 1988, FDA formalized what is known as the “fast track” designation, which permitted approval of drugs treating life-threatening or severely debilitating diseases after a single Phase II study."

http://www.raps.org/Regulatory-Focus/News/2015/09/24/23264/Studies-Raise-New-Concerns-over-FDAs-Expedited-Approval-Designations-Supplemental-Indications/

So why doesn't VOC qualify for approval now???

Isn't LN "severely debilitating"?

Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent AUPH News