When the CHMP recommend against marketing approval for PLX's enzyme in Gaucher (I was wrongly thinking PLX had a very good chance of bypassing Vpriv EU exclusivity then), it concluded that "Elelyso is similar to Vpriv, as they are both enzyme replacement therapies that work in the same way." Didn't matter how the enzymes were produced or their different glycosylation. Things could be quite different in court in patent litigation (I'm thinking of Enbrel). I don't know what strategy PLX would pursue in the AAT case if KMDA gets orphan exclusivity but they are holding an analyst day here tomorrow, so perhaps we'll have answers.
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