The questions were pointed, but they keep trying to add a huge amount of hypothetical and what it type things into the mix. The point here is: is the drug approvable based upon efficacay, safety as presented by the sponsor, and some go and twist it up with " I don't have alcohol pads in my office" therefore I can't administer this. A lot seem very disconnected from the real world given their out loud thoughts/comments. The "no" vote people wouldn't approve aspirin because not enough data. I was just taken back by a lot of the comments and the lack of connection especially for people in the medical field that have taken an oath to help humanity. Happy for the positive vote. You know, the first cars produced didn't have seat belts, turn signals, air bags, etc, etc. - every product goes through changes and tweaks to get it where it works optimally and REMS and dosing can all be worked on and improved after approval. Geezus, We have Windows 8 - - - and there will be more versions after that. Some of these people need to get out of their academic bubbles they live in. They want to review data data data for 100 years and then humanity has passed by. Anyway, I am happy that there were some good minds on the panel. Dr. Baxter summed it up very well when explain his vote - I believe him to have a great focused and balanced mind with common sense. I am sending Dr. Baxter a letter telling him that.
Sentiment: Strong Buy
A lot of the panalist remind of the nerds I knew in college - myoptic outlook - can't see the forest for the trees. I mean to say that a surgeon won't provide implant surgery at an office because they have to drive across town and it isn't worth the $20 ! - this was said during the meeting! For x-ist sake, YOU became a DR. and took an oath to serve humanity! and now during and FDA ADCOM meeting you share your feelings of not being paid enough to go help a patient????? UNBELIEVABLE how these people act! Purely disconnected.!
Psychiatrists are a strange group and I don't know how many no votes were psychiatrists. We had an expert panel of psychiatrists 5 years (top guys in the country) and one of them brought a wineskin of alcohol to put in his coffee at 8am. After that, I gave up understanding this specialty
Many were very inconsistent against their own logic. I think it came down to the fact that the Addiction Physicians are slowly learning that implant dose can be lower (and just as effective) as higher sublingual dose. The trials tested 2 doses that proved very efficacious. One clinician wanted a test with a lower dose implant than the 2 tested, and the other clinician wanted one with a higher dose. The fact is that these could be accomplished in phase 4 studies (post approval). The FDA must realize the expense drug companies must go through for each added dose -- and clearly they seem to understand the need for stable drug plasma levels to reduce addictive cravings.
Agree! The data was RIGHT THERE, but they couldn't see it! Can't see the forest from the trees. My degrees is in accounting and I have an MBA, I took lots of science in undergrad, bio, chemistry - a well rounded education - yes, I am not a Dr. or scientist - but for sake of gd - I could see the data and also understand that dosing can be tweaked/explored after approval - Titan said they were going to do that - yes, they will expand the product once approved - this panal seemed so short sighted !!!!