Monday, June 19, 2017 8:38:29 PM
Evaluate, let me first ask you this.
my answers in RED below.
If mPFS blended for the DCVax-L trial is somewhere between 16.0 to 20 months, do you see the primary endpoint having more or less chance of succeeding?
What is mPFS "blended"? I have been asking if you could provide the details on the components that might go into this "blend"
Does it include the PFS figures for those patients who started in placebo group & include patients who started in treatment group? If so, then aren't the "blended" estimates pretty vague? I thought the Primary Endpoint was to demonstrate a difference between treatment & placebo ... not some kind of blended figure. Say that the blended estimate is 18, with treatment at 18.5 and placebo at 17.5 ... then trial fails. But if blended is 18 and treatment is 30 and SOC is 6 .... then trial is a success. That is why I have been inquiring about your estimated breakdown. Are the blended estimates pretty much worthless & of no consequence whatsoever, unless viewed in regards to the breakdown between components?
If mOS blended for the DCVax-L trial is somewhere between 26.0 and 34.0 months, do you see the secondary endpoint having more or less chance of succeeding?
Same answer as above. Except here ... there is the possible confoundment of "early dcvax" versus "late dcvax" ... with 3rd component is "no dcvax". So what are your estimates for breakdown between these groups? Answer would be the same whether mOS blended is 10 or 20 or 30 or 40 or 50 .... that part is insignificant and not really worthwhile discussing ... unless there is further breakdown.
If the long tail survival (four years or more) for DCVax-L is above 29%, and if psPD 32 (24/8) arm merger into the 331 trial increases that to almost 36% for the DCVax-L arm, would you see the Phase III trial as more likely or less likely to succeed?
I do not have a clue regarding answer to this question. I do not understand the question. What is "psPD 32 (24/8) arm ". How do you figure there will be any merger? I think if the long tail survival (4+ years) is higher than 36% ... that sounds pretty good ... more likely to succeed?
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