InvestorsHub Logo
Followers 10
Posts 468
Boards Moderated 0
Alias Born 08/02/2012

Re: wshaw14 post# 2520

Tuesday, 02/21/2017 7:40:32 PM

Tuesday, February 21, 2017 7:40:32 PM

Post# of 4860
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/209531Orig1s000Approv.pdf

Quote from page 5 of the PDF file in the link above:

This voucher entitles you to designate a single human drug application submitted under section 505(b)(l) of the FDCA or a single biologic application submitted under section 351 of the Public Health Service Act as qualifying for a priority review. Such an application would not have to meet any other requirements for a priority review.

The bottommost sentence is the the key one. I would try to add emphasis, but I can't bold it through my phone.
Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent GILD News