A trial failing to meet primary endpoints, then finding hugesomesignificance in mortalitysome subsets of data, needs to be treated appropriatelywith healthy skepticism. The data generated that way is useful for developing further trials, as I've said before, but not useful for saying "the cells work".In a disease where ultimately people die at a high rate..... who would be more interested in the end points other than death ?
Doc Mcstuffins of course.
The FDA refused to allow MSB to select the primary end points for CLBP that would have been achieved. So, you cannot claim the cells don't work when the regulator is manipulating the companies end points. The cells don't work in accordance with how the FDA thought they should work, but they did in accordance with how MSB thought they should work, in all trials to the same extent. I'd call that evidence.
Hence, Docs' comments should be taken with a healthy dose of skepticism.
CLBP is 2-3 years away, and it will be their biggest indication.
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