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The Influence Of The Upcoming FDA Advisory Committee Meeting On NPS Pharmaceuticals’ Orphan Drug Gattex (Teduglutide) For Short Bowel Syndrome: Perspective

October 9, 2012 October 8, 2012 article gives an excellent explanation of the FDA Advisory Committee process : 

  1. FDA Advisory Committee meets on October 16, 2012 for Gattex for treatment of SBS
  2. Efficacy & safety data for Gattex is presented by the FDA & NPS Pharmaceuticals
  3. Vote is taken as to whether or not to recommend Gattex’s approval
  4. Emphasis on the fact that it is an “advisory” panel; FDA makes final decision on drug approvals
  5. FDA Advisory Committee panels are great “catalysts” for traders
  6. “Stocks are almost always halted on day of advisory panels”
  7. Are several interim catalysts leading up to the October 16, 2016 meeting :

              –  Release of FDA’s briefing documents usually 2 days prior to meeting

              –  Briefing documents usually includes FDA’s clinical review of Gattex.

Copyright © 2012-2013, Ann-Teresa Cusenza and Orphan Druganaut Blog.  All rights reserved.


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