Sat 12/15/2018 08:28 ET
DJIA24100.51486.832.02%TELCO165.080.660.40%GOLD1242.305.090.41%Shanghai2619.0714.930.57%
S&P 5002599.9549.661.91%BANKS395.493.760.95%OIL51.231.352.64%BITCOIN3266.0530.700.94%
NASDAQ6910.67156.182.26%PHARM563.0727.874.95%US/EU1.130.000.01%Futures2596.7548.821.88%
Welcome Stranger!  Please sign up or log in to enable additional features.Sign Up | Mail | Log In
Forum - Trevena, Inc - TRVN   

Msg Top | Msg List | < Prev | Next > | Post New | Reply | Privately | Search | Add TRVN
  
From: jloren1 (Rep: 3) reply to burpDate: 10/12/2018 07:52
Forum: Trevena, Inc - Msg #121Thread #674041006 (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...




Reply to burp - Msg #120 - 10/12/2018 07:17

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...
What would you like to do? Message: Endorse | Bookmark | Report AbuseUser jloren1: Reward | Watch | IgnoreTRVN: Ignore

Msg Top | Msg List | < Prev | Next > | Post New | Reply | Privately | Search | Add TRVN
  

TheLion.com | About Us | Agreement & Disclaimer | Privacy | Twitter
© 1999- TheLion.com, Inc.