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From: burp (Rep: 73)Date: 2018-10-11 17:29:21
Forum: Trevena, Inc - Thread #674041006Msg #113 - Part 1/6 (Rec: 0)
5:40 ADCOM vote was 8 no 7 yes.. 4 of the "no's said they were close to yes but data was inconclusive..
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From: jloren1 (Rep: 3) reply to burpDate: 2018-10-11 17:45:08
Forum: Trevena, Inc - Thread #674041006Msg #114 - Part 2/6 (Rec: 0)
Where did you see that 4 of the no's were close to a yes on the AADPAC webcast? Re: 5:40 ADCOM vote was 8 no 7 yes.. 4 of the "no's said they were close to yes b...
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From: almlk (Rep: 141) reply to jloren1Date: 2018-10-11 18:00:34
Forum: Trevena, Inc - Thread #674041006Msg #115 - Part 3/6 (Rec: 0)
October 11, 2018 / 12:42 PM / Updated 2 hours ago
Trevena's opioid painkiller fails to get FDA panel nod

1 Min Read

(Reuters) - An advisory panel to the U.S. Food and Drug Administration on Thursday voted against approval of Trevena Inc’s opioid injection for managing acute pain.

The decision comes as opioid addiction has emerged as a serious public health crisis in the United States, resulting in the deaths of over 70,000 people last year.

The panel voted 8-7 against the treatment, administered in hospitals and ambulatory surgery centres, that aims to manage acute pain in patients for whom an intravenous opioid is necessary.

Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Sriraj Kalluvila
Our Standards:The Thomson Reuters Trust Principles."
Re: Where did you see that 4 of the no's were close to a yes on the AADPAC webcas...


Reply to jloren1 - Msg #2756718 - 10/11/2018 17:45
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From: jloren1 (Rep: 3) reply to almlkDate: 2018-10-11 18:08:38
Forum: Trevena, Inc - Thread #674041006Msg #116 - Part 4/6 (Rec: 0)
Sorry still don't see it where it states 4 of the no's were closes to yes but found the data inconclusive. Looking for actual web page

Re: "World News
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From: burp (Rep: 73) reply to jloren1Date: 2018-10-12 07:17:24
Forum: Trevena, Inc - Thread #674041006Msg #120 - Part 5/6 (Rec: 0)
Re: Where did you see that 4 of the no's were close to a yes on the AADPAC webcas...

I Listened to the entire adcom live from 8am... it was pretty pathetic too...TRVN team was perfect..well prpared..answered every question with solid data... then the FDA had their turn... was like listen to a checkout girl at walmart chewing gum...ummm...ahhhh...ummmm... after the vote the independent panel had a chance to explain to explain why the voted yes or no....4 of the "no" clearly stated the efficacy was not an issue...but there simply wasnt enough safety data for them to vote yes comfortably....so TRVN goes into the PDUFA in Nov with just the safety in question...50-50 imo...


Reply to jloren1 - Msg #2756718 - 10/11/2018 17:45
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From: jloren1 (Rep: 3) reply to burpDate: 2018-10-12 07:52:32
Forum: Trevena, Inc - Thread #674041006Msg #121 - Part 6/6 (Rec: 0)
Ok, Thanks for the info. True DD to listen into the AADPAC live. Thanks for your insight on who was prepared and who was or who wasn't professional. TRVN going into the November PDUFA meeting with just safety concerns and possibly other concerns may require more data and studies. I'm not sure if a vote this close 8-7 is typical or normal I have never listened in. The FDA is tough and I bet they would have passed in the EU. I'm holding a small position and will hold for November. I think they are close to approval (50/50) if not now then down the road.

Re: Where did you see that 4 of the no's were close to a yes on the AADPAC we...
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