RE:RE:RE:RE:RE:RE:RE:RE:Optimized TreatmentI merely stated below without UUTUC. They could have taken patients with recurrent bladder cancer and no known UUTUC. Exclusion Criteria: 2. Has concurrent extravesical (i.e. urethra, ureter or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium
Macer wrote:
2b7f6fab wrote: Yes my Dr may not be aware of all the intricasies of running this trial although he indicated in times past he used to participate in trials, not anymore. However, Theralase/PMH seems to have accepted the worst of the worst for this Ph1b.
I read on this board sometime back that with theseUUTUC patients there was an 80% chance of recurrence at 90 days. My Urologist was unable to confirm this. However if true then 4 for 4 with no recurrence would represent a 1/625 statistical chance =(1/4^5). If 6 for 6 it moves up to 1/15625. Certainly not something that could be considered a chance happening. Obviously the treatment is doing what it was designed to do.
The Dr also explained for a bladder cancer patient without UUTUC they aim for no recurrence at 90 days. Once that is achieved then follow up is scheduled for 9 months later. I only bring this up because had PMH selected patients without UUTUC where would TLT stock price be now with 4/4 an no recurrence after six months? Efficacy in a Ph1b no less. Money would be pooring in here. Self funding for every cancer indication out there. This process of taking on UUTUC patients has really screwed the pooch regardless of what sort of data has been collected by treating the same.
Sounds great. But TLT did not get to select the group of patients that are eligible for the phase 1 study. Ethically, the treatment in general for early stages fo bladder cancer are rather successful so you cannot ethically take someone that has a good chance for success and use them for a study. They would be foregoing the approved and recomended treatment in order to enter the study to look at safety and tolerability. The Ethics board at PMH would not allow this to occur as there could be potential harm by avoiding the current treatment for the investigational one. This is why the group being studied needed to have shown failurre of the current approved treatments.
It would be interesting to see what optimization the team implemented after patient 5?
The delay between patients is because they would need to take any changes in protocol back to the Ethics committee for approval. They only meet monthly.
Macer