Ann: PARADIGM PROVIDES IND APPLICATION UPDATE, page-53

So many answers required, would create time issues for FDA.

3. Using nonclinical data or manufacturing information that does not adequately support the clinical protocol ultimately hurts the IND application.

It is critical to ensure that the nonclinical data supports the clinical design and that both provide adequate justification of the desired labeling claims, including basic exposure data. This requires detailed planning among your various teams and a strong knowledge base of the IND regulations.

Most importantly, specify how patient safety will be assured during the study. Include sufficient information to both assure the proper quality, purity, and strength of the drug or biologic, and to assess the adequacy and consistency of production.