Ann: Presentation- FDA Letter Requires Patient Instruction Update, page-67

The whole point here is that it is subjective - there is not a line pre-drawn in the sand that defines this. This is the WHOLE point why FDA needs to review it and it's not a box-ticking exercise. it's like that ad that went togs togs togs togs undies undies. We all have a different definition of where that line is. and as a group we would 'review the evidence' and determine where the line is.

BUT THEN! Each submission is the very first time ever that the drug has been looked at and needs to go through the review process and determine the requirements.