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Biotech / Medical : VD's Model Portfolio & Discussion Thread
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To: Rocketman who wrote (4466)3/24/1998 2:53:00 PM
From: Biomaven  Read Replies (1) of 9719
 
Rman,

Thanks for your comprehensive CBMI analysis. A couple of comments:

First, it's hard to fault them for including an x-ray followup. I can't seriously see them going to the FDA for approval without x-ray data.

Second, given that neither OP-1 nor autograft achieved their desired radiological endpoint, doesn't this just devalue the endpoint as unattainable at present? It doesn't detract from the apparent equivalence of OP-1 and autograft, which is all that is at issue.

I recall reading somewhere that the FDA was trying to reign-in its advisory committees and bring them back into the practical world. (I think this may have been a fallout from the Depotech debacle, where the rules changed mid-stream). If this is so, this might signal a reduction in the nit-picking approach that we have all come to know and love <G>.

Do you think that a Norian IPO would hurt CBMI/Stryker?

Peter
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