RE:I liked this point as well...vestor111 wrote: I liked seeing this point but I believe under the new FDA guidelines, TLT would be rated 100% CR due to the new guidelines allowing exclusion of patients found to be outside the scope of the trial. Recall it was determined that P4 had cancer that spread beyond the bladder and therefore beyond the scope of the trial.
The recent news from both patient five and six cancer-free status at 540 days from the Phase Ib study, which represents a 67% Complete Response ("CR") rate, supports the strong contention that the TLD-1433 Anti-Cancer Technology ("ACT") platform has the potential to be a viable treatment solution for CIS NMIBC BCG-Unresponsive patients, if the Company is able to duplicate the efficacy results observed in the Phase Ib clinical study."
This is where I am hoping that we see a positive suprise in the trial. My gut feeling is that due to the immune response associated with repeated treatment in study II there will be a lower than expected cohort of patients that have cancer that speads outside of the NIMBC classification. I think we can pretty much bank on a positive response in the trial, but throw in the immune response effect and overall better outcomes in all comers for the trial and this could have huge implcations for all of the other indications for TLD 1433.
Nice to see additonal sites coming on board, we shouls see the enrollement rate pick up pace now. Would be nice to see 6 patients treated in Canada by year end.
Macer