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BonelessCat

07/09/11 12:27 AM

#52564 RE: KMBJN #52563

The tox studies won't happen until after the pre-IND meeting. The pre-IND is to receive guidance for the tox studies which are the final step before filing an INDA which allows human clinical trials. At the pre-IND meeting NNVC will learn whether or not the two animal rule will be invoked. The two animal rule applies to drugs of expected low toxicity and allows tox studies and other testing to only require 2 species rather than 3 or 4. It also allows testing to skip Primates. Assuming the pre-IND meeting takes place before October, toxicology and pharmacological testing should begin no later than after the New Year 2011 and would be complete within 6 to 12 months after that.