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Sunday, October 30, 2016 9:32:43 AM
If you know something about these 8, please post it.
The Abstract says:
"A second cohort of patients with rGBM consisted of 8 patients with recurrence following several adjuvant temozolomide treatment cycles. Median OS for these patients is 14.7 months from the time of surgery for first recurrence. The comparator for this cohort is derived from Friedman et al. (2009), who reported mOS of 8.7-9.3 months from the time of first recurrence for rGBM patients treated with Bevacizumab with or without Irinotecan"
There are two errors here.
1. The Median OS for these patients was NOT 14.7 months it was 11 months.
2. Their comparator, Friedman 2009, did not report "from the time of first recurrence for rGBM". They reported from the time of randomization (a later timepoint than DCVax's "from the time of surgery". Freidman: "The median OS times from the time of random assignment were 9.2 months for the BV group and 8.7 months for the BV + CPT-11 group"
![](http://www.investorvillage.com/uploads/81923/images/8-patients-info-arm.jpg)
The Abstract conclusion says:
"These results suggest that treatment with DCVax-L can extend survival by 5 months or more in patients with rGBM."
And it should say:
"These results suggest that treatment with DCVax-L can extend survival by zero months in patients with rGBM"
But the good news for longs is that they don't have to worry about cross-over confounding the ITT OS analysis because this data suggests that DCVax doesn't do Jack in that population.
I wonder if that will make it into MD1225's upcoming SA article.
These people have, IMO, no business running a clinical trial in human subjects until they can:
1. Correctly design a trial,
2. Correctly assess the results of the trial,
3. Correctly interpret those results, and
4. Correctly report those results.
(Good luck responding to that w/o violating the TOS)
Finally, we have all lost loved ones to cancer. And we will lose more. It turns my stomach to think of the hundreds of millions of dollars that went into this program. And don't kid yourself, that money was diverted from other projects; as a society we only have so much to spend. The Woodford's of this world do not have bottomless pockets. The cure that could save your child could be sitting on a shelf somewhere waiting for the funds to bring it forward.
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