DNAprint Genomics (DNAG)

[worktoplay]

mahastock1...I hope they would take his advice as well, however, I would point out that if they do, his advice would have to be considered a significant adverse comment to the Race and Ethnicity rule as proposed. That would have the effect of taking the rule out of the fast track process and back to the normal regulatory timetable.

IMO, that would be a good thing in that it would stop the FDA from implementing a policy that favors subjective data over objective science. As Dr. Frudakis points out, it is now possible to determine quite accurately the precise BGA for clinical trial patients. The FDA should, as a matter of practice, seek not only an improvement in data collection, but should be looking to use the most objective methodology available for collecting that data. The primary goal in any scientific experiment is to limit uncertainty to the maximum extent practicable. A scientist cannot achieve consistent, reliable, repeatable results if there is uncontrolled variation in the base data.

If the FDA is truly interested in advancing their ability to study ethnicity as a factor in a patient's response to a given pharmaceutical, it would be foolish to ignore what is now possible using DNAPrint's BGA testing.

Later,
W2P