Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

Short answers
No, FDA does not always require control group in trials supporting drug approval. Some drugs have been approved based on uncontrolled trials. See: Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

Brilacidin rinse is given to prevent the development of oral mucositis during radiation treatment, if a patient develops SOM (ie. oral mucositis so bad that it might prevent rinsing) then it is a treatment failure, not a drop-out issue.