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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: Vector1 who wrote (7119)	9/30/1999 9:41:00 AM
From: biowa	Read Replies (1) \| Respond to of 9719

V1, <<The FDA problems are of concern to me. If it is so damn dificult to get a BLA filing why are so many other companies able to do it on time.>> If as suggested on the CLTR thread, CLTR wants more senior FDA folks there, isn't it kinda gutsy to not be nice in public? I'm also surprised that partner SKB hasn't been able to coach them better... Now from the way outer fringe: any chance the G-men will be revisiting the FDA after some Biologics mensch takes a cushy job at Idec or Genentech? That said, I haven't seen any technical arguments thrown at this molecule stick, as you said. And hasn't the company has been firm in saying no new data will be needed. Somebody would be sticking their legal necks out pretty far in saying that if the FDA had indicated a data deficiency. biowa