Printer Friendly

BIOWHITTAKER TO PROCEED WITH DEVELOPMENT OF TEST FOR ENDOTOXEMIA

 WALKERSVILLE, Md., Jan. 11 /PRNewswire/ -- BioWhittaker, Inc. (NYSE: BWI), announced today that the company has received a letter from the U.S. Food and Drug Administration (FDA) providing comments and recommendations regarding the company's submission of a "draft" Investigational New Drug (IND) application for its test for endotoxemia.
 The company plans to complete an in-house preclinical study before submitting a final IND application. A favorable FDA review of the final application will be required before BioWhittaker can begin clinical trials, and the company cautioned that there could be no assurance as to the timing or outcome of the FDA review process.
 Noel Buterbaugh, president and chief executive officer, commented: "We are encouraged that we are now able to move forward with the development of this product. In view of the need for a fairly comprehensive clinical trial, this process may take three to five years. Because the major market for our test will not develop until there is an approved therapeutic treatment for septic shock, I believe our entry is well-timed."
 BioWhittaker, Inc., develops and produces clinical diagnostic testing systems, cell culture products and endotoxin detection assays for the international health care and biotechnology markets.
 -0- 1/11/94
 /CONTACT: Susan Walden, director of communications of BioWhittaker, 301-898-7025, ext. 2559/
 (BWI)


CO: BioWhittaker, Inc.; U.S. Food and Drug Administration ST: Maryland IN: MTC SU: EXE

DC-KW -- DC006 -- 0831 01/11/94 08:13 EST
COPYRIGHT 1994 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1994 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Jan 11, 1994
Words:235
Previous Article:GTE SPACENET AWARDED CONTRACT
Next Article:CPA OFFERS PROTECTION FROM AN IRS AUDIT
Topics:

Terms of use | Copyright © 2016 Farlex, Inc. | Feedback | For webmasters