RE:RE:RE:RE:RE:RE:RE:RE:Critical Shortage of BCG and Adverse Reactions to Treatmentenriquesuave wrote: It could be in case of undiagnosed micro metastasis which would not be detected by cystoscope exam nor urine cytology? IMO. That way you maximize a durable response. Perhaps all patients may get a second treatment even if not CR after 90 days, but that's not how it seems outlined in original protocol and in FDA guidelines.
Got confirmation from the company that those patients who do not achieve a CR post first treatment, will not get a second treatment. They will be removed from the trial as per regulatory guidelines.
I agree the second treatment is geared towards improving duration of response...it would provide a more substantial/two-step treatment in the event any hidden cancer escapes interim assessment. And if they are assessing with both white & blue light cystoscopy (The FDA likely gave guidance on this), that would certainly beef up trial integrity...wherein initial CRs would be a much better predictor of durability. This is why a fast track designation imo is so meaningful. It indicates we have accomplished a minimum rate of CR. Considering our method of treatment & FDA guidance, a high CR rate should provide a good early signal of durability, which bodes well for a BTD...IMO.