Nothing in notes I didnt expect./Looks neutral to me.
Obviously results show their is a clinical benefit to Probuphine.Yes rescue drug will be needed for a subgroup of patients,but I always said Probuphine is for a niche market that will cater to a nice percentage of the Suboxone market, not to take over that market unless maybe 2nd or 3rd generation Probuphine is developed down the road.....
Limited rescue drug use Plus Probuphine implant for 6 months compared to daily dose of Suboxone for 6 months is still very beneficial on the Probuphine side..
Dont be so surprised by the FDA breakdown and statistics.Suboxone use/abuse has many serious issues itself that goes beyond any Probuphine concern and thats just a 1.5billion dollar a year FDA approved drug..Prouphine is just another treatment option desperately needed by this community and I think the benefits still outweigh the risk.
As for REMS proposal by Titan and FDA concern,well that is not unusual for FDA to debate drug sponsors initial proposal.Remember, Kate Beebe said thir REMS was just a preliminary draft and with guidance from FDA and Advisory committee members,it can be changed to satisfy the powers that be.
Also of note the new technique to insert and remove implants decreasing side effects was very substantial!
Well GLTA that held,and lets hope the Advisory meeting is convincing enough for a positive outcome...