I think their is a danger of FDA rejection for anal just based on the fact of n=11 is not enough. However, look at SRPT - this company gets FDA approval and sells their drug for muscular dystrophy and their is absolutely no statistical data that shows it works better than a placebo. Even the FDA admitted this and they sell it for 400k a year with medicare paying most.
So, it is a shame that 4,000 people a year with this deadly disease do not have access to something that appears to work awesome. Think about it, thousands of people are suffering and dying every year and their is as close to a cure as their can be right here!