Sunday, September 25, 2016 11:11:38 AM
Gabelli analyst Kevin Kedra believes that the positive outcome for Vantrela bodes well for DURECT Corporation's (NASDAQ:DRRX) and Pain Therapeutics Inc.'s (NASDAQ:PTIE) Remoxy, an oral oxycodone gelatin capsule for chronic pain.
The FDA has scheduled an advisory committee for August 5, 2016 to review the NDA for Remoxy. The FDA has requested advisers from both the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, as Remoxy is an opioid analgesic that has a unique abuse-deterrent profile.
Kedra points out that Vantrela panel provided greater insight on the FDA’s current thinking about ADOs and Remoxy’s probability for success. The analyst wrote, "We believe the FDA’s tone at the meeting and the favorable voting outcome are positive signals for Remoxy, which is expected to face an AdCom in August. The favorable tone and voting for Ventrela ER give us a greater degree of confidence that Remoxy will get a positive AdCom vote."
Read more: Positive FDA Committee Vote on Vantrela Bodes Well for Remoxy | Investopedia http://www.investopedia.com/articles/markets/061016/positive-fda-committee-vote-flibanserin-bodes-well-remoxy.asp#ixzz4LHI59OyF
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