Anavex Life Sciences Corp (AVXL)

[Steady_T]

Here is a bit more on the experience of the University of Iowa in obtaining an NDA approval just to provide a little insight into what is involved.

The NDA process is not for the faint of heart. For the University of Iowa, it was a
consuming four-year journey. Although NDA submissions are fully electronic, the 68GaDOTATOC
submission was over 1300 pages and included over 200 hyperlinked documents.
This is a remarkably short application by NDA standards, with its brevity attributable to the
substantial use of literature for non-clinical sections (animal study and toxicity data), and orphan
drug specific rules that allowed for fewer subjects in the pivotal trials that supported the
application. For perspective, this is 10-100X shorter than a typical therapeutic drug application
for a non-orphan indication. For an academic institution, the planning, drafting, assembly, and
electronic submission of the NDA to meet formatting requirements requires contracting with
consulting firms. The cost of the drafting and submission process will likely run into the
hundreds of thousands of dollars.

https://jnm.snmjournals.org/content/jnumed/early/2020/02/06/jnumed.119.238287.full.pdf