Biotech Values

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No, as pre-condition of Fabrazyme AA by FDA, a larger and longer duration randomized placebo controlled trial in similar but not identical population was conducted in many countries including US and EU where Fabrazyme was actually granted approval more than one year earlier than US under EMA's exceptional circumstances along with Shire's Replagal. FDA rarely if ever requires confirmatory trial in exactly same population as AA. They can also ask confirmatory trial to be substantially enrolled before filing, fully enrolled before approval etc. Thus this argument AA filing and approval prevents a placebo controlled confirmatory trial to be finished doesn't fly at all.