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Re: bladerunner1717 post# 149452

Thursday, 09/27/2012 12:03:20 AM

Thursday, September 27, 2012 12:03:20 AM

Post# of 257666

EC grants orphan designation to Endocyte ovarian cancer diagnosis method
On September 10, orphan designation was granted by the European Commission to Endocyte Europe for a method of diagnosis of positive folate receptor status in ovarian cancer, according to a posting made today to the European Medicines Agency website

Let's not put the cart before the horse. Diagnostic means very little if drug doesn't get approved. That said, given recent CHMP recommendation for approval of Avastin in similar, but healthier, ovarian patient population based on PFS benefit solely (#msg-79824816 ), I think it bodes well for ECYT drug's ultimate approval. Think question is more if EU will approve based on Phase 2 data or will they make MRK/ECYT wait until Phase 3 results are in hand?

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