It's obvious that the FDA wants to bring more options to patients than just BCG. And we have a track record that undisputably outpaces BCG alone.
So that's why Breakthrough designation will be granted.
Maintenance Bacillus Calmette-Guerin (BCG) — Maintenance intravesical BCG treatment is generally recommended for patients with high-risk non-muscle invasive bladder cancer (see "Patient education: Bladder cancer diagnosis and staging (Beyond the Basics)"). The benefit of maintenance treatment is that it may further delay recurrence and progression of the cancer.
Although the optimal duration of maintenance treatment is debated, several expert groups recommend that it be given for at least one year. Maintenance BCG is typically given once per week for three weeks at 3, 6, and 12 months after the initial BCG treatment. In some cases, maintenance BCG treatment will be recommended for one year for those at intermediate risk of recurrence and for three years for those at higher risk for recurrence.