Insightful's Sequential Trial SW Chosen by FDA

Insightful Corporation, formerly MathSoft Inc, a leading provider of solutions for predictive analysis, data mining and business intelligence, announced that the Food and Drug Administration (FDA) has chosen S+SeqTrial for use in the Center for Drug Evaluation and Research (CDER).

This division is responsible for reviewing and validating the assumptions, models and results of clinical trial submissions by pharmaceutical companies and medical institutions for FDA approval of new drugs.

S+SeqTrial uses monitoring and data analysis within a group sequential design to determine whether or not a study should continue. S+SeqTrial is widely recognized as a powerful new tool with the potential to cut costs and dramatically speed up the drug approval process.

"The Food and Drug Administration's decision to use S+SeqTrial reflects their recognition of the value of our modern approach to data analysis, which complements traditional statistical software such as SAS," said Shawn Javid, president and chief executive officer, Insightful Corporation. "We can help the pharmaceutical industry and the FDA streamline the data analysis process, as CDER has done by using S-PLUS and S+SeqTrial for clinical trial analysis."

S+SeqTrial helps biostatisticians evaluate drug efficacy data on an ongoing basis and perform interim analyses, saving valuable time and money. The software, combined with S-PLUS software, delivers professional, well-accepted tools for analyzing and presenting results for FDA reporting and greatly improves efficiency in the design of clinical trials. Biostatisticians can explore trial design tradeoffs from different interest groups including: the FDA, Data Safety Monitoring Board (DSMB) and business planners.

About S

S-PLUS is based on S, an object-oriented language licensed from Lucent Technologies specifically for data visualization, exploration and programming with data. S provides a rich, object-oriented environment designed for interactive data analysis and application development. With a large library of functions for all aspects of computing with data, S offers unmatched power, flexibility and extensibility. In 1998, John M. Chambers and the S System were honored with the prestigious Software Systems Award given by the Association for Computing Machinery. Other hallmark technologies recognized with this award include UNIX, TCP/IP, and Mosaic. More information is available at www.acm.org/awards/ssaward.html. Insightful Corporation has the exclusive, perpetual, worldwide rights to develop and distribute products incorporating the S technology.

About Insightful Corporation, Formerly Known as MathSoft Inc

Founded in 1984, and following its January 2001 sale of its Engineering and Educational Products Division, MathSoft now does business as Insightful Corporation. Insightful Corporation is a leading supplier of software and services for predictive analysis, data mining and business intelligence. Its customers include most of the major financial services, biotechnology, pharmaceutical, high tech manufacturing and telecommunications firms throughout the world, in addition to a large number of research institutions in government and academia. The company has more than 145 employees, with corporate offices in Seattle, Washington and Bagshot, England and an extensive network of international distributors.

More information about Insightful Corporation is available at www.insightful.com at 206-283-8802, by fax at 206-283-8691 or via mail at 1700 Westlake Avenue North, Suite 500, Seattle, WA 98109.

Contact Insightful Corporation, Judy McOstrich, 206-283-8802 x356, jmcostrich@insightful.com.