Chromatics Color Sciences International. Inc; CCSI Message Board

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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI

CCSI 23.55

+2.8%

12:12 PM EST

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To: eugenic1 who wrote (11)	3/8/1997 9:05:00 AM
From: Solarity	of 5736

Re-Posted from AOL: Subj: Re:ccsi Date: 97-03-06 23:02:04 EST From: Romacman Nice bounce off the 100 and 200 dma's. A friend told me to pick up some. We live or die by the fda nearterm, it appears. The fda has said the approval process for tech like this will be liberalized. There appears to be lots of upside from here. Are there any competitors with similar tech out there now? Should approval come, I agree, new highs seem very real. The float is not too big as to hinder a quick run. I have joined the group at the train station. Is it leaving soon? Subj: Re:ccsi Date: 97-03-06 23:44:57 EST From: BumperB I spoke to a friend of mine who works for a prominent biotech/pharmaceutical company about her take on the FDA process as it relates to the 510 K application process that CCSI is currently involved with. This friend of mine works in the capacity as a quality assurance/regulatory aid for the design and execution of clinical trials and all FDA submissions. This person interfaces with the FDA on a routine basis and fully understand FDA rules,procedures and policy. For the record, on no occasion has this person ever revieled any info to me about his/her company that could be considered priviliged. I asked this person if it was unusual for the 90 day period to pass without a decision from the FDA on a 510 K submission. I was told that the FDA has been trying very hard to adhere to the 90 day period but that of lately many 510k's were admittinly taking longer with very, very few going beyond the 120 day period. This was in fact recently printed in an FDA journal of sorts. I was also told that because the company was not at this point in time made aware of any serious problems-the outlook is extremely favorable. I am longer than ever yours, Bill

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