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Re: leifsmith post# 65906

Sunday, 02/24/2013 6:03:53 PM

Sunday, February 24, 2013 6:03:53 PM

Post# of 146240
It's hard for me to guess when tox testing will be done. A lot depends upon which sort of tests are required, and I don't know what they are. Looking at the web sites of various labs that do such testing, it is clear that chronic toxicity testing is much more time consuming than acute toxicity testing (no surprise there). If chronic toxicity testing is required the tests could take 6 months or longer. I will be generous and assume that the start of tox testing is consistent with the stated times of "June +/- 3 months". I will be realistic and assume that that means "end of September, 2013". So if chronic toxicity testing is required I don't expect the tests to be completed before the end of March, 2014. It will be some period of time after that before the FDA gives IND approval. So, if all goes reasonably well I hope to see phase I trials start early in 2015, all of this assuming no inordinate delays in the construction of the manufacturing facility.

This estimated timeline will get the usual vitriol from daBoze and Puffer. When actually it is lightening speed compared to what NNVC has done for the past 8 years.

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