Ok, now I would like to respond to the FDA’s Disapproval Response item #2 regarding
“But did not substantively respond to our statistical recommendation” and “We continue to request that you please consider addressing these statistical concerns in order to improve the quality of evidence the proposed registry will be able to generate.”
Great the FDA want’s the stats. Here they are:
The power of a statistical test is the probability that the test will reject the false hypothesis.
Power nearly always depends on the following three factors:
1. the statistical significance criterion used in the test (statistical significance is a statistical assessment of whether observations reflect a pattern rather than just chance.)
2. the magnitude of the effect of interest in the population
3. the sample size used to detect the effect
So for starters let's lay out the data as we all know it.
People in the World With MS
People in the US with MS
People in the US on an FDA approved DMD
People in the World who have had PTA to unblock veins
People who have been cured of MS
People who have been cured of MS using PTA therapy
So let us roughly test these constants for sensitivity
DMD Sensitivity to a cure
Sensitivity to a cure using PTA therapy.
Infinitely greater sensitivity that PTA therapy for CCSVI helps MS more than an FDA approved DMD
Sensitivity to the word "May help" in drug literature regarding FDA approved DMD's
Sensitivity to the word "May help" in CCSVI literature
Sensitivity to the using a cane in x number of years
7 years with PPMS Unknown number of years after PTA treatment for CCSVI
Sensitivity to using a cane with RRMS
20 years Unknown number of years after PTA treatment for CCSVI
Next I will calculate the odds that these helpful FDA agents may or may not contract MS.