66% the number to beat...In the 2Q2020 newsletter, page 3 under "FDA status update" Theralase said" Theralase would potentially be eligible for BTD & AA, if TLT could demonstrate clinically significant results, similar to the safety and efficacy results(66%CR) observed in the phase 1b NMIBC clinical study at an interim analysis of approximately 20 to 25 patients."
Let's see what advantages phase11 has over Phase1b...
Phase 1b Phase 11
Number of patient treated.
6 .....................................................................30(and growing).
Number of treatments.
1 .................................................................... 2 (0 and 187 days)
Optimized treatment.
NO .................................................................YES
Optimized laser.
NO .................................................................YES(Pressrelease June 27, 2019).
Doctors experience working with
patients &TLD-1433.
Little experience..............................................Approximately 5 years(big difference).
CR%.
66% ................................................................???
The phase1b 66%CR was achieved with only one treatment, using a non optimized treatment, a first generation laser, and the doctors had minimal experience working with TLD-1433.
Note:The second treatment at 187 days will increase the CR% big time at 270 days.
With all the positive changes made in the phase11 trial, there is no way the CR% is going to be under 70-80% CR.