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What is an expected timeline for the development of an IND application to proceed from preclinical studies to clinical studies?

April 26, 2017application clinical Development IND preclinical proceed timeline

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What is an expected timeline for the development of an IND application to proceed from preclinical studies to clinical studies?

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Specialized Centers can propose preclinical studies in the first or in the first and second year. The IND should be developed during this time so that clinical studies begin no later than the beginning of the third year of the program. A pre-IND meeting(s) should be held with FDA to discuss milestones for filing IND.