Ann: Update on meeting with US FDA, page-31

The thing I don't understand is that the FDA do not award Qualified Infectious Disease Designation to potential IND's where testing did not comply with US GLP regulations, they most certainly do not waist their time with face to face meetings with drug companies presenting them with non compliant GLP material, also I do not see why constant reference to the IND acronym is so important when they are at the stage of talking to the FDA about Phase one Human trials because it is obvious that IND approval is needed to start those trials. IMO DYOR