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Biotech / Medical : CTEC: Cholestech any other investors?
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To: Duane L. Olson who wrote (409)1/14/1998 4:28:00 PM
From: David Martin  Read Replies (1) of 710
 
According to the Company's prospectus, the clinical trial is expected to last until April or early May, after which time a decision will be made regarding seeking FDA approval. Assuming a positive clinical, it would take another 2 to 3 months for preparation of the FDA application. Approval to sell the product is expected in late 1998.

It may be possible to sell the product in Canada or Europe earlier than these time frames because the regulatory requirements in these countries are not as strict as FDA.

On CLIA, once the technology is confirmed at Cleveland the Company would proceed on its application. Its a pretty simple product!

Have you called the Company? They are small, so let me know if they are helpful and/or responsive.
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