The FDA didn't make comment on efficacy.
They didn't say it was efficaious, nor did they say it wasn't. A lack of comment doesn't constitute an affirmative, although that's what people are implying.
What they did say is the trial was too deficient to consitute adequate evidence. So it's simply impossible to make any comment on efficacy without proper scientific evidence. When there is a properly controlled trial, then the FDA will comment on efficacy.
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