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Re: DewDiligence post# 67280

Friday, 10/10/2008 6:18:43 PM

Friday, October 10, 2008 6:18:43 PM

Post# of 257570
Its not surprising it got pulled. The fda had disagreed with them on stats. fda switches a few things around and they just missed significance. So I think the fda as much as told them it wouldn't be approved for acute without more work. FDA may even be gaming it to make sure there's two sources of supply. In reality it won't make much difference commercially, people will use it as they need it and not stick to the label. I do expect CSL to get approval for the acute indication some time in 2009. Both will essentially be interchangable. My total guess levp (vphm) ends up with about 80% share C1 acute+prevention, first mover advantage, good relations with the hae association and more nimble than the large CSL where C1 probably doesn't move their needle a ton.


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