RE:pharmaguy and other experts..Q for you.. FDA ADcom BD'sI won`t answer these questions specifically because I strongly believe the people with positive sentiments here are on the money.
Being in regulatory, experience only gets you so far, especially in the field of innovative drugs because there`s a guarantee that every submission will be different. From Pre-Clinical, to RA Filing, no two submissions ever go exactly alike.
But I`ll fill you in on some side information that has me confident.
I know Telesta has hired the MAPI group to handle all of their regulatory affairs. This group does not come cheap at all, they have nearly all their staff attend training and conference events all over the world, and they conduct their own training sessions for small and large companies. They are at the top of their game.
The submission is in good hands, and I am still betting on a positive result come February. That being said, I will reiterate my past statements: I was also expecting the adcomm to go better, so I`m definitely not infallible. If it were up to me, I would have handled it a little differently.