I wonder if TTNP & Braeburn have tried to file for "breakhrough" product designation?
"The FDA's new "breakthrough" product designation allows new drugs to win approval after just a single round of testing, instead of the usual three. A total of three promising experimental medicines have been assigned the new status so far, while an additional 18 drugs have applied. The new designation follows three other programs -- Fast Track, Priority Review and Accelerated Approval -- each of which were designed to help bring crucial new drugs to market in a shorter amount of time.
"A breakthrough drug is one that may offer important new benefits for patients with serious or life-threatening disease who are especially in need of new safe and effective treatments," said Janet Woodcock, director of FDA's Center for Drug Evaluation and Research."
NOTE: The above was copied from headline on DNDN page. GLTA!
What would be the point now? I believe that CLSN got that designation and they were able to skip a P3 trial. They filed the NDA after a P2 trial only. Titan already conducted a P3 trial, a confirmatory P3 trial and a long term trial.
I understand your point, of course, because we are late in the process, but if granted, the designationt would enhance commercialization. After all, it is a "breakthrough" product for the opioid addiction treatment space. It never hurts to ask......... GLTA!