Amicus would be all over the proteinuria statistics required by the fda, and the levels of proteinuria (reduction by % also) being factored into fast track approval criteria by Parasol. Our dèal struck that very next day after the fda ann.
so, by looking at the blinded data, they have draw their own observations, but I do think the conclusions they made to sign the deal were not that; yes the drug works over placebo, we all know that, but they believe that dmx200 works to fit wìthin the fda requirements, this is key.
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