RE:RE:FDA Approval for TLD1433 pdt almost certain IMHO
Kingpin68 wrote: Eog, what do you make of the wording here : 'Of the patients who achieved an initial CR, 46% (n=23 of 50) continued to remain free of high-grade recurrence at 12 months.'
Why ' high grade recurrence '. Is low grade recurrence acceptable. And how does that compare to TLD's partial response numbers. Isn't a partial response the same or similar to being free of high-grade reoccurrence?
To put it simply, low-grade recurrence is acceptable per FDA guidance. A partial response reflects either a low-grade cancer within the bladder or it simply represents a "yet to be determined" status wherein confirmation of cancer existing outside of the bladder is still pending.
More technically, a PR is defined as a patient who either displays a positive cystoscopy & negative urine cytology or a negative cytoscopy & positive urine cytology. A positive cytoscopy can represent either low-grade or high-grade NMIBC. In a patient that has a negative urine cytology & a low-grade form of NMIBC is detected (meets PR criteria), such a patient can be re-classified as a CR. A patient with a negative cytoscopy but positive urine cytology can also be reclassified as a CR when it is confirmed by CT or other method that there is also cancer present in either the upper or lower urinary tract (i.e. ureter/kidney or prostatic urethra, respectively). Good luck...