"CR at any point in time'While we're waiting, here is an interesting thought.
1) In the May 28,2021 pressrelease TLT said" Study11 has a Primary Endpoint of efficacy, defined by Complete Response" (CR) at any point in time".
2) In the 2Q2020 newsletter TLT said" In a 3Q2019 conference call with the FDA, it was discussed that TLT would be potentially be eligible for BTD and or AA, if TLT could demonstrate clinically significant results, similar to the safety(100%) and efficacy(66%CR) results observed in the Phase1b NMIBC clinical study at an interim analysis of approximately 20 to 25 patients enrolled and successfully treated".
Note 1) The 66%CR being the final results, consequently it does become "66%CR at any point in time" for the Study1b trial.
In the Nov 29,2022 pressrelease the "CR at any point in time" is 26/43 patients = "60% CR at any point in time" up till now for the phase11 trial.
As more and more optimized patients are treated the CR "at any point in time" will increase.
As we speak the CR at any point in time could be easily be over 65-70%CR.
Given time it could easily surpass N803+BCG(71%CR at any time(Eoganacht posting)).
Note 2)The 450 days 28%CR is for the secondary endpoint of duration (the fact that it is steadily increasing is a very good omen for TLT).
Note 3) In the Nov29,2022 pressrelease, the terciary endpoint is safety(100%). Peoples on this board have no idea how big 100% safe is for the FDA. It does mean that no patients will die using TLT treatment, and the FDA will not be endangering patients lives by approving TLT treatment.
In short...As we speak TLT has...
-A treatment that could already have a CR at any point in time over 65-70%CR in the phase11 trial(with only half of patients treated in the phase11 trial, it is extremely good).
-A treatment that could already surpass the 66%CR at any point in time of the Phase1b trial(2Q2020).
-A treatment that could already surpass the CR at any point in time of N803+BCG.
-A stand alone-treatment(doesn't need BCG)
-A treatment that is 100% safe.
-A treatment that cost less than competition.
-etc...
Note 4) Every time the SP is stuck at a new level, somebody start to talk about a PP.
Who care about a pp, a pp will not change the fact that TLT has the best, most affordable and safest treatment that the FDA coulfd offer to patients that were 100% guaranteed to lose their bladder.
Question?
Could a treatment that is 100% safe and as we speak could have a 65-70%CR at any point in time(and increasing) be good enough for BTD&AA?
Tough question, for the FDA.