>Drawing up such a dossier is a profession in itself. An important detail: the EMA is asking for around €350,000 to assess the book.

This is a massive understatement of the regulatory hurdles at play. I have worked on dossiers that took 200 man-years at 400k per person. This is the development part of pharma R&D. The dossier might be a thousand pages submitted, but that can easily be 100,000+ pages on the backend.

There's a reason that even billion dollar companies crumble and fail under the documentation complexity.