RE: What am I missing?"let's say, we test the cow in winter and eh look the percentage is not that different. Then we do the same test during summer, whoo big difference."
You are absolutely correct, as stated in the following report.
"Abstract Fecal prevalence of Escherichia coli O157 in ruminants is highest in the summer months and decreases to low or undetectable levels in the winter."
https://www.springerlink.com/content/9410205466018011/
Therefore (and was part of my inquiry) winter testing provides no meaningful data due to the absence of the host that the tests are being based on.
With that being said, did not the preface to Bioniches submission make the obvious statement that the host has to be present in order for the test to have any meaning? Would they not have presented data showing the seasonal activity cycle of e-coli in bovine sheddings?
I am at a loss as to how this was missed by either Bioniches submission or the USDA's analysis of the data.
So there are 3 tentative conclusions
1)The vaccine works as stated and Bioniche just botched the submission.
2)The submission was clear and the USDA is just giving them a hard time.
3)The data does not support Bioniches claims.
There is other data which seems to minimize the probability of it being #2. The CFIA in there report to Bioniche made this statement."the CFIA indicated that Bioniche was required to provide additional data confirming reduction in E. coli O157:H7 shedding by vaccinated animals"
So by simple extrapolation the CFIA has stated that the data that Bioniche provided to date has not confirmed the reduction, therefore a licence can not be granted until they do so....How is that any different than what the USDA has stated?
So it seems that it is either #1 or #3. I hope for the faithful that it turns out to be #1. If so, then they need to get their act together and provide both the CFIA and the USDA with the conclusive data necessary to support licensing.
Time will tell.
Good luck.