Wednesday, February 23, 2011 2:57:41 PM
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We've done informal tox studies over the course of almost 3000 animals
No toxicity, resistance nor side effects were ever found
However, you only do a formal tox study AFTER the pre-IND meeting
They give you guidance as to how many and what type of animals they want in the study
For example, TamiFlu was required to do mice, ferrets and chickens
Often they ask for a small and a large animal but we won't know until after the meeting
It would be foolish to waste the time, energy and money on a tox study that has no meaning to the FDA
Sincerely
EUGENE SEYMOUR, MD, MPH
Chief Executive Officer
NANOVIRICIDES, INC
Nanotechnology-based targeted anti-viral therapeutics
http://www.nanoviricides.comeugene@nanoviricides.com
310-486-5677
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