RE:Has to be over 60%CR... After that press release , they no longer used the 67% CR for AA, they wrote from very clear memory " if significant efficacy" is achieved. I believe we have achieved that already for BTD. That should open the door for AA as we are already beating Adstiladrin in efficacy, less side effects and less treatments. On all fronts IMHO
wildbird1 wrote: I am one of the very few people on this board that come up with a CR% over 60% in Dec 2022, for the first 25 patients.
My Dec 12,2022 post was 71%CR/29 patients for the BTD application in Dec 2022.
Let"s me explain why the CR% has to be over 60%CR in Dec 2022.
PressRelease May 29,2020.
3) Breakthrough Therapy Designation, TLT said..."Continuing the FDA conference call, it was further discussed and agreed that Theralase would potentially be eligible for BTD and/or AA, if Theralase can demonstrate clinically significant results (high safety profile and high efficacy response), similar to the safety and efficacy results observed in the Phase 1b NMIBC clinical study(high safety profile and 67%CR) at an interim analysis of approximately 20 to 25 patients enrolled and successfully treated".
The most important word is "similar" to the 67%CR, for me similar is anything between 60-70%CR at 450 days.
Important note: It doesn't say, TLT will apply for BTD approval in Dec 2022 with a 30-40-45% CR%, NO! What is clearly stated is that TLT need a CR% that is at least over 60%CR(similar to 67%CR) to apply for BTD in Dec 2022.
The above mean that if TLT does apply for BTD in Dec 2022, the CR% on 25 patients at 450 days has to be over 60%CR(or the agreement with the FDA is invalidated).
Take the time to reread the May 29,2020 PressRelease, and if nobody can prove me wrong on this one, my over 60%CR in Dec 2022 stand. And if my over 60%CR% stand, it can only mean that TLT is heading for a very big deal with a big Pharma in 2023.