Did you follow the mention about the Brazil label? I took a quick look and didn't see a "black box" but as I recall it noted immunogenicity, injection site reactions and the like. I didn't compare the percentages to what Cerezyme has in their label but guessed they would be similar... me being lazy as you know thought I'd ask you :-).
I heard Shire present a little while back (didn't hear their quarterly) they played down the PLX launch saying very limited use and it'd depend on the label.
Just so other people know I have know position in PLX and am unlikely to buy (or for that matter short) anytime soon. I follow more the space and am curious how their oral program develops.
Shire's Replagal is already the market leader for the treatment of Fabry disease and its new manufacturing facility in Lexington allows it to increase supply if needed.
As for Gaucher's disease market: "Shire anticipates regulatory agency submission of the VPRIV (velaglucerase alfa) manufacturing process at the new Lexington manufacturing facility by the end of 2011." Meaning more capacity around the time PLX should get approval.
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