I'm not arguing ANY of your DD. To be honest, you probably understand all the TECHNICAL #$%$ more than I do. That being said.... How did the board, that the FDA pays, to do all of the "preliminary" findings, and reading through all the studies, effectiveness, and blah blah blah, come to an OVERWHELMING 10-4 YES vote, and then have the FDA shoot us down like we were fish in a barrel? Wouldn't THAT imply that the FDA had some MUMBLING, STUMBLING, BUMBLING, going on in their own back yard?
All I'm saying is that my hopes were never higher about the outcome of Probuphine than after the Adcom meeting and vote. My hopes were dashed when the SAME entity then shot us down. THAT will forever boggle my mind, and leave me NO OTHER reasonable conclusion, other than someone paid off the powers that be, to further delay this product.
Your above explanation, basically never answered my REAL QUESTION... How does the FDA have a final decision of NO, when their paid panel, of highly trained experts, recommended a YES vote, by a margin of 10-4? Why would the FDA even bother hiring the panel, if they aren't going to listen to their recommendation, and over rule it? MONEY, is the ONLY REASON, that I can come up with.
Ok, Jodie....You have some valid points in this post, HOWEVER....You seem to ALWAYS CONVENIENTLY, leave out what I would call the MOST CRITICAL POINT.
IF there was so much "mumbling, stumbling and bumbling," going on, and such BLATANT inept management errors upon errors that took place..... HOW, IN THE WORLD, did they still manage to get a 10-4 APPROVAL VOTE, and once they got that approval vote, HOW DID IT GET TURNED DOWN, BY THE SAME ENTITY??
I STILL think someone did a "sweet heart" deal on the FDA side. Just my opinion.
HAPPY EASTER, to all the "Old Timers", and "Newbies" alike!!!