Thursday, January 24, 2008 7:18:03 PM
I guess what I don't understand is exactly what the consultants do for a submission like the one made to Psychiatry. My sense from the FDA website is that they favor an interactive process when putting together and IND. While we don't know what Laughren was thinking exactly, the decision made wrt COR fits with what appears to be a very conservative policy at the FDA. In the context of such a policy, the FDA could have communicated to COR that any such submission would be held to very high standards.
Arguing this point is pretty futile now. I would be grateful though, if someone could clarify what consultants would do in this kind of a situation, other than assess risk.
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