
Wednesday, August 17, 2022 8:05:11 PM
Rereading my old notes, I must admit that my prediction of the number of non-crossover placebo patients alive at 36 months from surgery is wrong.
Let me explain.
There are 3 placebo patients on the PFS KM curve with confirmed disease progression between 30 and 31 months from randomization = between 33 and 34 months from surgery.
I think radiographic evidence of disease progression by independent radiology review was confirmed between 35 and 36 months from surgery. So, the 3 patients were still alive at 36 months from surgery.
The 3 patients received their last placebo dose 30 months from randomization. I thought that the next step was an End Of Treatment (EOT) Visit and that the crossover option was no longer offered at the end of the study. I put them in the non-crossover placebo group but that was wrong. They got the crossover option, IMO.
NYAS DATA = PFS KM curve. https://investorshub.advfn.com/uimage/uploads/2022/5/11/jjgyh5-10-22-Slide-11.png
13 placebo patients at risk at 24 month from randomization.
Zero placebo patients at risk at 36 months from randomization.
5 placebo patients with confirmed disease progression between 24 and 31 months from randomization.
8 placebo patients censored between 24 and 36 months from randomization.
A closer look at my “notes about censored placebo patients” also dampened my expectation.
I think only a few non-crossover placebo patients are alive 36 months from surgery, all with a poor prognosis.
All IMO.
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