20-25 patients...If you read the last May,2023 Corporate Presentation.
Page11, under Clinical Target.
TLT said..." Strong safety and efficacy clinical data on 20-25 patients would support a BTD".
Note: 20-25 patients(that was in May,2023).
In the Aug 29,2023 press-release TLT said..." once the pre-BTD submission has been approved by the FDA, the company plan to compile a BTD submission for review by the FDA(4Q2023)".
Optimized patients protocol.
The optimized treatment protocol is the only protocol that has been approved by the FDA for all future patients starting Aug 20,2020, since only the optimized patients are included in that protocol, it will be logical for TLT to use only the 29 optimized patients data(TLT need only 20-25) when TLT will compile a new set of data for the BTD submission (4Q2023).
Should TLT decide to use only the 29 optimized patients data for BTD submission...the data will be as follow...
Press-release Aug 29,2023.
29 optimized patients data at 450 days.
34%CR (complete response).
7% IR (indeterminated response).
41% CR+IR (Total response).
Note: The 41% Total response is the number of patients that still have their bladder after 450 days and counting(not bad).
34%CR is 42% better than Adstiladrin(24%CR), approved by the FDA.
34% is also 79% better than Keytruda(19%CR), approved by the FDA.
All the above bode very well for TLT treatment BTD approval, since Adstiladrin with just 24%CR and a very big immuno-deficient restriction did get BTD approval from the FDA.
The SP.
TLT is just a small cap company on a small exchange, with no real revenue, and no FDA approved treatments, as a result the SP value is exactly as it should be.
But once TLT do get FDA approval and big pharma deals(with an s), the SP will climb to a better exchange and more.
As we speak, for the very first time since that story started, with the pre-BTD submission TLT has a big and strong foot inside the FDA, with a treatment 42% more potent than the best treatment already approved by the FDA(Adstiladrin 24%CR)
Knowing the above give you kind of a nice and reassuring feeling about your investment in TLT.