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jq1234

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jq1234

Re: DewDiligence post# 162935

Sunday, 06/23/2013 2:34:58 PM

Sunday, June 23, 2013 2:34:58 PM

Post# of 257302
Orphan exclusivity regulation has many flexibilities building into it, thus lots of subjectivity under different circumstances. Shire's Vipriv for Gaucher got Orphan exclusivity in EU only after Genzyme Cerezyme manufacture issue caused shortage, otherwise it wouldn't have, thus PLX's Elelyso would have got approved in EU.
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