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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI -- Ignore unavailable to you. Want to Upgrade?

To: Clayleas who wrote (1900)	4/29/1998 11:43:00 PM
From: JanyBlueEyes	Read Replies (1) \| Respond to of 5736

Don't Worry About SpectRx As shown below SpectRx has not even begun to manufacture these devices in any quantity and has only recently leased space THAT IT PLANS TO USE TO MANUFACTURE ITS PRODUCTS. What a joke!! From SpectRx 10K-405 --> filed on 3-27-98 sec.gov To date, the Company's manufacturing activities have consisted only of building certain prototype devices and pre-release versions of its BiliCheck(TM) and BiliCal(TM) products. If the Company successfully develops its diabetes screening and infant jaundice products and, together with Roche Diagnostics BMC and Respironics, obtains FDA clearance and other regulatory approvals to market these products, the Company will undertake to manufacture these products in significant volumes. The Company has no experience manufacturing such products in the volumes that would be necessary for the Company to achieve significant commercial sales. There can be no assurance that the Company will be able to establish and maintain reliable, full scale manufacturing of these products at commercially reasonable costs. Although the Company has leased space that it plans to use to manufacture its products, it may encounter various problems in establishing and maintaining its manufacturing operations, resulting in inefficiencies and delays. Specifically, companies often encounter difficulties in scaling up production, including problems involving production yield, quality control and assurance, and shortages of qualified personnel. In addition, the Company's manufacturing facilities will be subject to GMP regulations, including possible preapproval inspection, international quality standards and other regulatory requirements. Difficulties encountered by the Company in manufacturing scale-up or failure by the Company to implement and maintain its manufacturing facilities in accordance with GMP regulations, international quality standards or other regulatory requirements could result in a delay or termination of production, which could have a material adverse effect on the Company's business, financial condition and results of operations.