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Thursday, December 10, 2009 11:03:46 AM
The FDA's involvement can and should begin long before the IND filing. The biggest mistake start-up BioPharmas often make is not taking advantage of FDA seminars and conferences during the early development of new drugs, treatments, and therapies. The company's officers met with FDA several times and those meetings are in the public record. What isn't in the public record is advice and guidance offered in 2007 toward filing that eventual IND.
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