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Thursday, August 09, 2018 4:13:01 PM
I personally think I'm accurate on the 64 censored patient count - and I think biotrader came up with the same number. So if 64 are alive, then we are missing 44. And we conveniently were told 44 lived past 36 months. And the two and you have 108 patients alive in March 2017, and that is the number the journal said were alive.
So now, I feel much more confident that my step downs, or OS events are close to, if not completely, accurate. That means there are 14 patients, give or take a few, not on the chart.
In my opinion, the only place they can be is as OS events past 36 months.
And if that's the case, those 14 OS events are what established the 88.2 KM-derived mOS.
And if I'm right, then that means that 44 + 14 patients, or 58, made it past 36 months.
That would leave 64 patients between the months of 18 and 36 who have a chance to make it to 36 months and beyond. And given that they've made it to 18 months minimally, their odds of doing so would have to be significantly improved than if they were starting at month zero, or even month 12.
I mean, they've passed the 14.6 average for all of GBM patients, and they were at month 18 or higher back in March 2017, which seems to be the higher median OS accorded these days to GBM patients lately.
So let's look at that.
36 patients were between months 18 to 24. - my guesstimate: 26/27 months?
20 patients were between months 24 to 30. - life expectancy mentioned at ASCO: 38 months
7 patients were between months 30 to 36. - life expectancy mentioned at ASCO: 46.5 months
18 to 24 months
36 patients - one half make it to 26/27 months. So 18. They now have a life expectancy of at least 38 months. At least one half make it to 38 months.
So lets go with one more than half, or 11, make it to 36 months.
24 to 30 months
20 patients - Their life expectancy is between 38 and 46.5 months. More than one half will make it to 36 months
So I'll guess 13.
30 to 36 moths
7 patients - at least one half make it to 46.5 months. So many more than one half will make it to 36 months, that's 10 months earlier.
So I'll guess 5.
Therefore, if around 58 already made it past 36 months, then 11 + 13 + 5 mean 29 more, or 87 patients could make it to 36 months.
87/331 = 26%.
That number should improve if the last 31 patients were all treatment, but we don't know for sure where those extra 31 treatment patients fit.
But I think we can see that at least 25% of all the patients in this trial will make it to 36 months. And if the KM-derived mOS stays consistent, then those 87 patients would have a life expectancy of 88.2 months. That means that 1/2 of them will be under that, and 1/2 of them will be over that.
Or 44 patients from 331 will for certain live 7.35 years. That's 13%.
If that's how it ends up, that data beats Optune's 13% at 5 years by more than 2 full years.
AND THAT IS COMBINING THE PLACEBOS WITH THE TREATMENT PATIENTS. The treatment arm alone HAS TO BE EVEN BETTER.
Given that, it's difficult to see how this data is not approved when it's eventually set forth in a BLA before the FDA. And there is just no way this company will not do a BLA, when they are ready, be it in the next few months, or the next six months.
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