[digler999]

> a regulatory environment that requires

the regulatory environment only "requires" this if your drug doesn't work as advertised. The other way to get your drug approved is to, you know, not make phony claims about its efficacy.

[paul_f]

If you don't know how and when and where and exactly what format to file your documents, you don't get approval. Simply working isn't sufficient. It's a complex process and having well connected experts is of extreme value.