RE:Accelerated Approval - what are the chances?What's even more in our favor is that the FDA doesn't only consider CRs but TRs (CR + PR). So our TR for the optimized group is already above 50%.
Considering what's at stake, bladder removal, anything that can delay its removal or that can preseve it, should be welcomed and offered as a new alternative to patients. That's the spirit of the AA program.
_____________________
Eoganacht - (12/8/2022 1:28:48 PM)
Accelerated Approval - what are the chances?
8 out of 29 patients (28%) have hit at least 450 days completely cancer free.
Remove the 12 undertreated from the calculation to see just the optimized resu ( these 12 are mostly little different from the first 3 half-dose patients from the phase 1b ) and you have these optimized results at 450 days:
8 out of 17 ( 47% ) patients cancer free (including 3 full dose phase 1 patients) and
6 out of 14 ( 43% ) patients cancer free (including only phase 2 patients)
Surely those numbers, along with the extremely high safety, should be enough for AA.
I'm sure the 6 phase 2 patients who no longer have bladder cancer think so.