The best approved treatment...If you want to know if a treatment is good enough for BTD approval, you compare it to the best treatment already approved by the FDA, that has received BTD approval.
The best treatment already approved by the FDA for BCG-Resistant patients, that has received BTD approval is Adstiladrin with a 24% CR at 12 months.
Some debbie downer pretend that TLT is in trouble...it is not TLT that has a problem, it is our closest competitor at 24%CR.
The debbie downer never talk about the fact that TLT Ruvidar has a 36%CR at 12 months, 50% better than Adstiladrin that did get BTD approval.
Yes! Until TLT Ruvidar get BTD approval the SP will stagnate, but knowing that no other FDA approved BCG-Resistant treatments has a 36%CR at 12 months is kind of reassuring for the BTD approval of TLT Ruvidar.