...that the 1993 trial of the photodynamic compound photofrin for the treatment of non-muscle-invasive bladder cancer resulted in approval in Canada. But the treatment was never used because of "severe and long lasting side effects".
Nonetheless 61% of patients from that trial were recurrence free after one year.
There was never any question that TLD-1433 is a far more effective pdc than photofrin so there is very little doubt that TLD-1433 pdt will do much better than 61% CR at one year.
The phase 1 trial already demonstrated safety so it's clear what the overall results of the phase 2 trial will be. It's just a question of waiting for proof of what we already know is going to happen.
Once 25 patients have been treated in the phase 2 trial we can start the clock. One year later Theralase can apply to the FDA for accelerated approval. Chances are excellent that the CR rate at one year will be at least 61% and Theralase will be able to commercialize it's treatment long before the trial is officially over.
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