azure, de Moivre "discovered" the concept of "normal distribution". In 1738 he published the second edition of “The Doctrine of Chances.” Pearson said it best,“ ...the normal curve is beautifully simple, and we may use it as a first approximation, particularly in theoretical investigations.
My understanding is the PPHM data presented at ASCO withstood the "null hypothesis" at the 95% confidence level. Can someone verify that? CJ? Maybe I'm remembering wrong. Tests of normality measure the chances that a given data set {x1, …, xn}, or trait(Bavi test results) comes from a normal distribution of measured traits vs. the alternate, that the measured trait distribution is arbitrary.
About 68% of values drawn from a normal distribution are within one standard deviation s > 0 away from the mean µ; about 95% of the values are within two standard deviations and about 99.7% lie within three standard deviations. This is known as the 68-95-99.7 rule, or the empirical rule, or the 3-sigma rule.
As a rule of thumb, 2 standard deviations past the mean is considered significant. That's the 95% confidence level. Scientific inquiry into biological systems presupposes flexibility because of infinite variation, but 2 standard deviations from the mean, or 95% confidence level, is acceptable to infer that there is, in the case of Bavi, biological activity. Nothing is ever completely certain, but the closer 100% is approximated, the mre certain.
The India tests on Bavi reveal that even though it is chimeric in construction, that is, has mouse protein parts rather fully human parts, and must induce some body reaction against that protein, the MAB still creates what is almost certainly a net positive when mixed in the cancer chemotherapy mix. Bavi does not reduce reduce chemotherapy efficacy, but almost certainly adds to the cancercidal effects without adding complications. Adding naked Bavi to standard chemotherapy protocols actually facilitates clean-up after chemo-kill, and probably increases survival time. The chemotherapy industry cannot be thrilled. MAB-Bavi can deliver with pinpoint accuracy a tiny dose of the same chemo agents or better--park it alongside cancer where it explodes the tumor like a suicide bomber. And a little naked Bavi in the mix helps tidy up afterward. The cancer chemo companies are accustomed to cancer patients wallowing in cytoxins taken orally or intravenously. So quantity demand for the same crowd of chemo- warhorses, cytotoxins will surely diminish in the next decade as medical science converts from gross total-body chemotherapy to specifically guided tumor-site MAB delivery systems like Bavi.
A caveat: normal distribution is a simple and convenient model to use, but sometimes researchers assume that trial data is distributed normally rather than skewed, and efforts have not been made to measure the skew. An example is assuming outcomes in Bavi would be the same between Indian castes, or caucasians, without measuring the assumption. It is said that the maturity [or immaturity] of a scientific field can be judged by the prevalence of the normality assumption in its methods.
source: Wikipedia "Normal distribution"
—
