DNAprint Genomics (DNAG)

[DougS.]

It is funny and a little ironic that you would ask me:
"Why do you think the FDA is developing the guidelines"

Seeing that you never had the courtesy to answer that question I don't see why I should answer it myself but I'll give it a go anyway:

I think the FDA needs a data template to evaluate pharmacogenomic data in a fair and conclusive manner. Not only does there need to be a format but there needs to be a way of separating out useful data from, well, mere data. I mentioned to someone earlier that the current process is akin to everyone filing their taxes on a scratch pad with no formating or standardization. How would the IRS begin to process taxes in such a manner? The FDA currently faces a similar problem. It has very little to do with classifiers and very much to do with the current state of the drug development. The generation of genetic data is a reality that now extends to every facet of the pharmaceutical world.

The focus of the pharmaceutical industry, IMO, will always be on new drugs. It's more profitable. If there was truly an interest in classifiers then you would see them appear shortly after guidance was issued. After all, the guidance isn't stopping anyone from developing classifiers, only getting them approved. Right?

Headed out now. Have a good New Year.