Sarepta has a remarkable business model: they have proven that efficacy is not required when you bring motivated parents to bear on the FDA.

This being the case, what are the odds that the FDA would yank their gene therapy if the confirmatory study "failed"? Wouldn't they have to yank the entire Sarepta portfolio, since none of their products has proven itself in confirmatory studies? The odds are nil, thus the Elevydis confirmatory study is for show.