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Re: Echo20 post# 47176

Wednesday, 03/09/2011 10:38:47 AM

Wednesday, March 09, 2011 10:38:47 AM

Post# of 146242
The FDA requires GLP-run toxicology studies to allow for an IND filing. Generally speaking, and especially for non-life-threatening diseases where there are other therapies, at least 2 animal species have to be tested in chronic and acute toxicity studies. The cost and length of these studies is minor. So it begs the question why NNVC hasn't ran GLP-compliant toxicity studies since they are a gating factor in IND filings.

cGMP manufacturing would follow the solution of GLP compliant drug supply.

The way I see it, NNVC will be preclinical forever at this rate.
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