Derudover havde virksomheden ikke fremlagt tilstrækkelig dokumentation til at påvise, at Advexin kunne fremstilles på pålidelig vis, eller at det ikke var skadeligt for miljøet eller for personer i tæt kontakt med patienten.
In addition, the company had not supplied enough evidence to demonstrate that Advexin could be made in a reliable manner, or that it would not be harmful to the environment or to people in close contact with the patient.