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newman2021

06/06/24 9:40 AM

#696519 RE: flipper44 #696514

flipper, if they go for both nGBM and rGBM like they did in the UK, then I think they forgo the Orphan Desig, imo. The Company spent more than half a billion dollars in the trial and US has the most trial sites. Obtaining a PDUFA date would be a huge plus, imo.