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BonelessCat

08/10/09 9:02 PM

#23026 RE: Blither #23025

Antiviral animal tests, which are part of the pre-clinical Human-use testing process, can be done at any lab certified for that particular virus type. It doesn't matter whether the facility is a medical school, veterinary school, school of health or a school of bioengineering. Moreover, for some time now, the CEO has been talking about developing a viricide for animal use as a shortcut to market. Animal use has a much shorter testing time frame than human use, and after filing for animal use could be approved in a year to 18 months. This is a far shorter time frame than that required for Phase-1, -2, and -3 testing.

All the testing completed at LSU's Thevac can be and will be used in both USDA and FDA review. Animal testing results from a veterinary school can be used in an FDA IND application provided all the testing meets with the guidelines set by the FDA.