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Biotech / Medical : BICO & VITK
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To: Tom R. Jones who wrote (2142)9/7/1998
From: ackbh  Read Replies (1) of 2395
 
Tom,

Not sure that we should read too much into this other than the fact that the FDA feels that they have enough technical information and no further clarifications on the data of the clinical trials that gave CE Mark approval. Now they are working with Biocontrol to finalize submission for the approval process. I would think that they should be on fast track to get either another panel discussion for approval or further testing. Either way they can now sell outside the U.S. and this should help prove the safety and efficacy in the near term.
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