RE:Better than "BCG".Oden6570..ask, does today's news mean that our current phase 2 CR results are improved due to FDA guidance?
Short answer YES, as some patients with cancer cell outside the Bladder wall could be clasified as CR ( complete response).
wildbird1 wrote: Clinical study results are very complex and confusing. But if you take the time to read them a few times , you can connect the dots, and have a better understanding of the results.
Better than "BCG".
The primary purpose of the study11 is to discover if the TLD-1433 are effective in the destruction of "BCG" unresponsive non-muscle invasive bladder cancer.
Question?
What is a "BCG" unresponsive patient? A "BCG" unresponsive patient is a patient that doesn't respond to standard treatment, and has only two choice left...
1) Removal of the bladder and replacing it with a pouching system(bag).
2) Go home and die,(some patients do refuse the bag system).
Let's recap.
- There is no effective treatment for "BCG" unresponsive patients (except pouching bag).
-TLT was given the task to treat only the worst of the worst patients.
- 4 patients will undergo a CT scan, to rule out UTCC , if UTCC is proven to exist , according to FDA these patients will be clasified as CR ( Complete response).
Meaning; These 4 patients suspicious Cytology results could come from cancer cells outside the Bladder wall, and TLT wasn't allowed to treat the surrounding tissues only the Bladder itself.
- 3 patients had a complete response(maybe more after the 4 patients CT Scan).
Conclusion:
1) "BCG" couldn't treat these patients.
2) Because TLT could only treat the worst of the worst patients, and 3 patients(maybe more after CT Scan) have been given a second chance and going home with a complete response, TLT has already proven that TLD-1433 can treat patients that "BCG" couldn't treat.
Not bad for a trial were all patients were undertreated.