RE:RE:RE:RE:RE:Pioneering is never easy...The way I look at Pre-Btd is advisory in nature. Sort of like a filtration process. FDA may encourage TLT to apply formally for a BTD. The critical factors would still be an "un met need". We now know there Keytruda and Adstilarin that have full FDA approval to treat NMIBC. Let us hope we have more clarity in tomorrow's Zoom call. Nobody wants more excuses or opaque answers.