[mattkrause]

Exactly.

Here's literally the law on what goes into a New Drug Application: https://www.law.cornell.edu/cfr/text/21/314.50

The idea is that it serves as the "whole story" of a drug, and includes everything from preclinical data demonstrating how the drug works on a molecular level, up through the plans for actually manufacturing and administering it. Thus, it includes a lot of things "for the record". For example....

If the application relies on material published in another language, then you are required to submit the original and a translated copy. It is very unlikely that the FDA is going to retranslate each article.

Similarly, you need to include individual case reports for any trial participants who die/drop out from adverse events even if in the placebo group and the cause is unrelated to the drug. If Mrs Jones from the control group got eaten by a shark after getting the placebo, a bunch of her medical info will be in there. This a) bulks up the application and b) slows down redaction but c) takes a reviewer about two seconds to realize they can ignore that entire section.