Well I have no idea what B16 melanoma is (I think it is only in mice) so we have cured mouse Melanoma (somewhere a vet is trying to figure out how to make money with this)
On a serious note, I read an article on Forbes last week talking about the FDA and how they were restructuring their approval process. It gave me the impression that the FDA is giving out BTD prior to a trial, then providing extra regulatory supervision through the trial to ensure the company meets their requirements and can make changes as it goes. If ONCS has applied for that, it may not be them we are waiting on, but the FDA to give a thumbs up.
Just a thought, take it for what little it is worth