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Alias Born 09/18/2006

Re: gfp927z post# 1198

Tuesday, 09/19/2006 9:18:27 PM

Tuesday, September 19, 2006 9:18:27 PM

Post# of 50407
One opens an IND for a particular compound and particular indication, regardless of division. The division that reviews it is the division that the particular indication falls in. Given that, the FDA does allow you to conduct 1 trial under another IND. In this case, the ADHD trial under the Alzheimer's IND. Going forward, we will need a new IND and I hope, given their confidence that the FDA will lift the clinical hold, that they are preparing the IND, phase 2b protocol, etc., so we can get the ball rolling as soon as possible if needed.
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