The FDA will grant us Breakthrough based on these questions
It all comes back to these questions?
- Does this treatment give more options to patients, for them to spare their bladder?
- Does the FDA have the luxury, yet, serious arguments, to not make this treatment available to patients?
- Does this treatment deliver higher efficacy results than competition?
- Does this treatment offer high safety profile?
- Does this treatment achieve its primary, secondary and tertiary endpoints?