Remember that when the FDA refused to approve DNDN's drug, despite its proven efficacy (because someone on the final committee was working on a rival drug -- sickening) -- the patients contacted their Senators and congresspeople, and the threat of a Senate subcommittee investigation made the FDA reverse its decision, so that the drug was approved.

Do you think that oncologists and cancer patients would be any less vocal if there were a safe oral rinse that could prevent oral mucositis in about half of the patients who would normally get it? (using historical data instead of the atypically low rate of the placebo group in the IPIX study)

If for some reason the FDA were to fail to approve Bril-OM despite great results, I can't imagine that the American Cancer Society, oncologists, and patients wouldn't be outraged enough to organize and lobby their congresspeople. It's lots easier now, with the online petition sites that reach millions of people.

Please note that I absolutely would expect the FDA to approve Bril-OM with the results we've had -- I'm just saying that in the (in my opinion) unlikely event that there were a snag, there are a LOT of people who would want this drug and would lobby to get it.