I have a lot of opinions here for all sorts of reasons. First I strongly believe that we should have access to whatever information such as this that may affect our health as possible. However, l also would like information we can depend on. There is a suggestion that perhaps some of their procedures are not correct. Not producing required paper work gets a company off on the wrong foot. Not doing required studies for labeling gets a company off on 2 wrong feet. When the California Dept. of Corp. wanted a report, my clients were all over me for whatever was needed ASAP. There may have to be no label claims of diagnoses for instance. Wordings may have to be changed. There has to be some kinds of studies documenting what they are doing and how arrived at. The data is likely the sum of all the items a person answers to sign up and any studies they run with selected or specially recruited persons.
First of all collecting data and doing something with it is something I have been doing since the late 70s, writing HMO and insurance claims paying, membership, antifraud, medical records, data mining and the like. Whatever labels got put on it, that is what I did. I did everything from design screens and paper forms to complex databases and complete HMO systems, claims systems, management reports, audits of many kinds and so on. I saw lots of data. So let's look at what this is about or may be about. There were some definite missing research needed to validate their model of what they are doing. I have no doubt that it at least in part involves the SNPs themselves and the correlation with all those answers each person gave while registering to put their DNA into the system. Having gone through their questionnaire process I choose not to do their program. This whole generation of data they were collecting is flawed, in certain ways to an unknown extent, for at least some uses, in my opinion. One can tell a lot by what they ask or don't ask. A major focus of mine for the past 30+ years is how to design a medical records database to maximize correctness, which for use with patient results considerations for treatment.
I don't know what the FDA has seen or not seen. I suspect that the claims they appear to be making are not supported by the data or they haven't supplied the studies or modified studies requested by the FDA over an extended period of time. So they will prepare their answers. What concerns me more is if they are getting some of the science wrong It's important they get things correct or say that they don't know. I'm not talking about being a little plus or minus on a percentage but something really outright wrong. That is based on the answers to their questions. There are also answers based on theories of various kinds. How valuable such interpretation has or hasn't been for successful treatment is something each person who has tried it must answer for themselves.
Now as many know, my major interest in all this is the whole B12 and folate deficiency universe including CFS, FMS, ME and all the rest. Allow, for the sake of this discussion, that I have an understanding about this specific problem that may be the fundamental foundational understanding of this whole business despite some imperfections. If I am at all correct about the variables needed to solve the MYSTERY DISEASE many of us have (b12/folate deficiency diseases minus everything satisfactorily corrected by CyCbl, HyCbl and folic acid, which leaves 90+% of symptoms in place and improves some mix of the others) they did not ask the correct questions to receive the answers needed to solve our problems.