And they will limit their scope to TTNPs delivery system, etc. VERY good news, imo.
During this meeting, representatives from the Agency and the Applicant will present:
? Data from the clinical trials performed to assess the efficacy and safety of
Probuphine in the treatment of opioid-dependent patients:
o While the study design (randomized, placebo-controlled, parallel group
study of 6-months duration) is not novel, some of the analytic approaches
and concepts are.
o Because the systemic safety of buprenorphine has been characterized, the
safety presentation will emphasize information about adverse events
associated with the surgical implantation and removal procedures.