Titan Pharmaceuticals Inc (TTNP)

[Doctor Detroit]

Well said. For those unfortunate families trying to cope with that insidious, formless, unfathomable disease, I feel nothing but compassion. Unless you've dealt with it firsthand, it's impossible to understand the senselessness of the disease. Our strengths as humans--logic and willpower--are helpless before it.

For the FDA, I feel nothing but disgust. Yes, probuphine should have been approved in 2013. It only wasn't because the FDA moved to goal posts.

Now, in 2016, with a clinical trial showing superiority to SL buprenorphine under all but the most negatively drawn evaluation criteria (and even then non-inferiority admitted by the FDA), probuphine remains unapproved. Not for efficacy or safety, but because, in my belief, the FDA is scrambling to find some sort of condition to approval (a phase IV, a labeling change) that will prove they were right not to approve probuphine in 2013.

They are unable to admit a mistake and do the right thingIt is better in the FDA's eyes that addicts die than they admit a mistake.