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Biotech / Medical : Ciphergen Biosystems(CIPH): -- Ignore unavailable to you. Want to Upgrade?

To: D.Lu who wrote (484)	2/23/2007 1:49:03 PM
From: tuck	Respond to of 510

First, at the bottom of my last post I mis-typed: I meant ASR or Analyte Specific Reagent. CIPH once hoped to get their test approved under this fairly quick and lenient process, but the FDA apparently did not buy it. So now they must file for approval as an in vitro diagnostic test. The potential routes there have different time lines for review. If they can get it under the 510(k) process, the review period is 90 days. If they must go the PreMarket Approval route, the review period is 180 days. In either case, the FDA can ask for more data or something and reset the clock. See this: fda.gov See also: fda.gov as I think this applies to CIPH's test. Is it a class II or III? I'm not sure. Since the apparent demise of the ASR strategy, I haven't heard what regulatory path CIPH intends to try. A listen to the CC might have the answer. I haven't gotten 'round to it. Cheers, Tuck