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Re: TRUISM post# 5473

Monday, 06/08/2015 2:51:52 PM

Monday, June 08, 2015 2:51:52 PM

Post# of 16911
Great news today!

There was one thing that gave me just a bit of pause however:

A total of 23% of Probuphine treated subjects and 13.5% of subjects in the sublingual buprenorphine/naloxone group had an implant site adverse event, the majority of which were assessed by the clinical investigators as “mild” in severity.



Does that seem high to anyone? Almost a quarter of the Probuphine group had some kind of issue with the implant? Although it does claim to be "mild" for the majority, so perhaps that would include any kind of mild skin irritation as well? Any thoughts from the group on this? Feel like this could be one of those things we get more info on if there was any kind of push back from FDA..

Don't think it's a big deal and obviously the overall results weigh much more heavily than this, just wanted to play devil's advocate for the only thing that came out of the call that wasn't completely positive.

Congrats to the group & trial participants.

B
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