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Ubertino

12/10/09 9:13 AM

#25831 RE: mkendra #25830

If an IND was not submitted we are years away from any drug to market. Is thnere any way to find out? I mean other than from the company. Perhaps the FDA has a list somewhere available. Let me look:

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm

We are likely in pre IND consultation but even that is a WAG.

Slow aren't they!
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BonelessCat

12/10/09 11:03 AM

#25835 RE: mkendra #25830

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.