Reneuron - second time lucky?

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thenaughtyboy - Tue, 02 Jan 07 :



"85% of ALL IND Applications move on to begin clinical trials"

Assuming the company decides to pursue human studies, it must first submit an Investigational New Drug application to the FDA for approval. The IND becomes effective 30 days after receipt by the FDA (assuming the FDA does not require further information), and must be filed annually thereafter until the completion of clinical testing. The IND must provide pre-clinical data of sufficient quality to justify the testing of the drug in humans. About 85% of all IND applications move on to begin clinical trials. Assuming the company receives FDA go-ahead, the company will move the drug on to Phase 1 testing in human subjects. At this point, the compound has a one-in-five chance of eventually reaching the market, and will normally take another five to nine years to reach that destination.


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