RE:RE:RE:RE:RE:RE:RE:RE:RE:Keep patient, maybe we are at last step to the final victoryThanks Eog. I've always felt that this is what has been happening and TLT has just been framing it as pre-BTD.
Reading up on CGON and others I think one big protocol goof that they did was around bladder biopsies. CGON, which has bladder biopsies (random sampling of a bunch of spots) at 12m if I recall the details. When you have urine negative cytology, confirmed by a central lab, rather than some smaller distributed labs, negative scope and negative biopsy (essentiall triple checking for cancer) you have a CR with a lot more conviction than without all 3. My hunch is that the fda, being nitpicky, said that if you don't have a biopsy you need further out data to corroborate that patients are truly CR and not just having the cancer come back later. Put another way a triple confirmation at 12m is equal to a non-biopsy (i.e. 2/3 methods) confirmation at 18 months. Plus they didn't have the central lab part.
So my hunch is that the following happened
1. Preliminary Breakthrough Therapy Designation Advice Request was held and the advisor didn't say NO or YES but rather, maybe but you need more information (central lab and further out data) to compensate for lack of biopsies and to just be more confident.
2. This means that the meeting resulted in a neutral opinion about the BTD step. They may have felt that if TLT can show the extra items then bring back to the Prelim request and go from there.
IMO