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DragonBear

10/21/19 11:25 AM

#104708 RE: Jimmy Joe #104691

Ask them.

That question is already answered. Try the FDA website on the purpose of the 3 Phases. What is required.

Ever been a part of a FDA inspection? They can be so twitchy, at least for GLP. One can only imagine how they are in reviewing 20 yr old data. Sloppiness is not overlooked. Well, except in Kenny's world.