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Biotech / Medical : VD's Model Portfolio & Discussion Thread

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To: Miljenko Zuanic who wrote (4473)	3/24/1998 11:21:00 PM
From: Rocketman	Read Replies (1) of 9719

mz, I see it as a crapshoot in that FDA OK in the short term is no certain thing, it could go either way. I put this in a class with CEPH, a definite maybe.....toss the dice and see how it comes out. Long term, I think they've got something and can ultimately get approval. I'm just not sure that the FDA will be in a rush to approve this. If the endpoint is supposed to be equivalence to current procedure of using autografts, and "radiographic assessment of the number of patients with cortical bridging remained approximately 10% higher for the autograft group", then, they haven't shown equivalence. Keep in mind that these are not clinicals where you have to show you are better, but just equivalent. I'm not sure how readily the FDA tends to approve when one of the endpoints doesn't show equivalence for non-lethal conditions with a current acceptable procedure. Even when equivalence is the endpoint, I suspect what the FDA is still looking for is something that is functionally better. This is no sure thing. As far as comparing the market caps of SEPR and CBMI, one is a pharmaceutical company and the other a med device.....you are comparing apples to oranges. Rman

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