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Wednesday, 02/23/2011 2:57:41 PM

Wednesday, February 23, 2011 2:57:41 PM

Post# of 146296
Earlier today, I sent a communication to Dr. Seymour about the confusion and frustration regarding taking the TOX package to the FDA. WHY IT HAS NOT OCCURRED ? Below is his response :

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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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