Thursday, October 25, 2018 9:13:02 AM
Agreed in general it looks like more of a 2 than a 4, but was curious what other might get from the content.
Regarding the 290 event number. A few months ago there was a seeking alpha article about the calculation of events in the phase III trial from beginning to May 2018.
https://seekingalpha.com/article/4170868-cel-sci-simple-math-appears-imply-phase-3-success
The author created a calculation based on the cancerresearchuk Head & Neck cancer which has some of the most up to date and conservative survival % available.
Based on the curve of events he deduced that we should have already reach the 10% improved survival mark.
However Lightrock and I had extensive discussion on this board, wherein primarily light rock noted a flaw in the bases the author had used, which the author then corrected.
I however went a step further, as the author had only included one type of head and neck cancer, when based on the clinicaltrials.gov website the trial is also recruiting other oral cancer types. Some of these with better prognosis. I then re-did the survival calculations to take into account the incidences of these other cancers and the most available data on their prognosis to arrive at what I believe to be a more accurate depiction than that of the author's. I then used the same curved calculations as the author but utilising my new and even more conservative numbers. Adding on the continued average number of expected deaths past May 2018 within a given time period, my calculation would have us at about the 290 mark.
Feel free to go though my Cel-Sci posts as I believe I have a link to my most recent calculation spreadsheet in there, as well as another post which explains how I calculated the more conservative numbers based on the complete set of oral/head and neck cancer types which are eligible for recruitment.
While I also feel it is likely 2, even if it were 4, the sample size was very low so the FDA may not have felt it had the power to be fast-tracked anyway.
Regarding the 290 event number. A few months ago there was a seeking alpha article about the calculation of events in the phase III trial from beginning to May 2018.
https://seekingalpha.com/article/4170868-cel-sci-simple-math-appears-imply-phase-3-success
The author created a calculation based on the cancerresearchuk Head & Neck cancer which has some of the most up to date and conservative survival % available.
Based on the curve of events he deduced that we should have already reach the 10% improved survival mark.
However Lightrock and I had extensive discussion on this board, wherein primarily light rock noted a flaw in the bases the author had used, which the author then corrected.
I however went a step further, as the author had only included one type of head and neck cancer, when based on the clinicaltrials.gov website the trial is also recruiting other oral cancer types. Some of these with better prognosis. I then re-did the survival calculations to take into account the incidences of these other cancers and the most available data on their prognosis to arrive at what I believe to be a more accurate depiction than that of the author's. I then used the same curved calculations as the author but utilising my new and even more conservative numbers. Adding on the continued average number of expected deaths past May 2018 within a given time period, my calculation would have us at about the 290 mark.
Feel free to go though my Cel-Sci posts as I believe I have a link to my most recent calculation spreadsheet in there, as well as another post which explains how I calculated the more conservative numbers based on the complete set of oral/head and neck cancer types which are eligible for recruitment.
While I also feel it is likely 2, even if it were 4, the sample size was very low so the FDA may not have felt it had the power to be fast-tracked anyway.
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