Titan Pharmaceuticals Inc (TTNP)

[Doctor Detroit]

Pro Neura

From Zacks report:

During the Probuphine approval process, Titan gained substantial experience and knowledge regarding the ProNeura implant that we believe will substantially reduce the time and risk of developing follow-on products. Much of the safety work for the implants have already satisfied the FDA s concerns with the Probuphine trials. One of the key concerns for the FDA was related to the training and certification component required for the implantation and extraction procedure. Both Titan and Braeburn have developed effective, efficient and approved protocols for training and certifying providers to work with implants. Vendor relationships are also much stronger and more developed than they had been in the past allowing for rapid turnaround and adjustment of product to satisfy evolving needs. Since neither ropinirole nor T3 are controlled substances, we believe the end products will not face
as much resistance as implantable buprenorphine did. As a reminder, robuphine was required to be distributed via the Risk Evaluation and Mitigation Strategy (REMS) program due to buprenorphine s classification as a controlled substance and due to the training and certification component. Future implants may not be subject to this restriction and additional hurdle.