T Cell Sciences' Product Pointers For 1995 Growth

23 January 1995

US company T Cell Sciences Inc has issued a progress report on its product developments, which it says highlights the products that will point to growth for the firm in 1995.

TRAx CD4: early in 1994, T Cell agreed with the US Food and Drug Administration to run a supplemental clinical trial to compare TRAx CD4 with flow cytometry as part of its submission for 510(k) approval. This trial was completed successfully and confirmed the results of the company's initial trials, the results of which were filed with the agency in June of last year in an amended 510(k) of almost 1,500 pages with data from approximately 1,000 patients and seven clinical sites.

In December 1994, the FDA asked for clarification of this submission relating to individual data points, precision data on kit components and changes to the proposed labels and package inserts. While it is never possible to predict the final decision of the agency, T Cell says it views these latest requests as progress toward getting this key product launched in North America.

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