InvestorsHub Logo
Followers 35
Posts 4660
Boards Moderated 0
Alias Born 12/14/2013

Re: None

Wednesday, 10/02/2019 9:07:57 AM

Wednesday, October 02, 2019 9:07:57 AM

Post# of 33211
Seems Like the below could be bad or maybe good? news for ENDV since it shows FDA is open to alternatives to opiods


DURECT Announces FDA Advisory Committee Meeting to Review POSIMIR® for the Treatment of Post-Surgical Pain

CUPERTINO, Calif., Oct. 2, 2019 /PRNewswire/ -- DURECT Corporation (DRRX) announced today that the U.S. Food and Drug Administration (FDA) has notified the Company that its Class 2 NDA resubmission for POSIMIR® (bupivacaine extended-release solution) will be discussed at a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). The meeting is tentatively scheduled for January 16, 2020. The FDA had previously assigned a user fee goal date of December 27, 2019; a new user fee goal date has not been assigned.
DURECT commissioned the advisory services of Dr. Lee S. Simon to lead the Company's preparation efforts to prepare for the advisory committee meeting. Dr. Simon is a physician and research scientist who served as the FDA's Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products from 2001 to 2003, and is now a Principal at SDG, LLC, an FDA advisory firm.
"We look forward to a productive discussion with the advisory committee," stated James E. Brown, President and CEO of DURECT. "If approved, we believe that POSIMIR could help address an important need for new long-acting, non-opioid pain products in the post-operative pain setting."
Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent ENDV News