Corporate | 25 July 2012 21:19
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WILEX AG / Key word(s): Miscellaneous
PRESS RELEASE WILEX AG reports on Oncologic Drugs Advisory Committee (ODAC) meeting and positive vote on diagnostic imaging Munich, Germany, 25 July 2012. WILEX AG (ISIN DE0006614720 / WL6 / FSE) reports that on 25 July 2012 the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) discussed the question: Would an imaging test provide useful clinical information if it identified only clear cell renal cell carcinoma (ccRCC) within the kidney of patients with an indeterminate renal mass? ODAC voted by 16 to 0 (1 abstention) in support of the imaging information being clinically useful. Before the vote the ODAC was asked by the FDA to discuss in what clinical situations and in what patient populations an imaging test that only identifies ccRCC within the kidney in the diagnostic work-up of an indeterminate renal mass would be clinically useful or lacking in clinical utility. After the vote the ODAC also discussed to what extend the performance characteristics of the imaging test (sensitivity / specificity / reproducibility) determined in patients undergoing resection of a kidney mass providing histopathology as standard of truth could be used to estimate how the imaging agent would perform among patients who may be managed with ‘active surveillance’ rather than surgical resection. As the ODAC provides FDA with independent expert advice and recommendations, the final decision is made by FDA. Based on the recommendation WILEX and FDA will discuss the further development strategy of WILEX’s diagnostic candidate REDECTANE (R) in a meeting which is planned for September 2012.
About WILEX AG
Website: http://www.WILEX.com, ISIN DE0006614720 / WKN 661472 / Symbol WL6
Contact WILEX
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End of Corporate News 25.07.2012 Dissemination of a Corporate News, transmitted by DGAP – a company of EquityStory AG. The issuer is solely responsible for the content of this announcement. DGAP’s Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de |
| Language: | English | |
| Company: | WILEX AG | |
| Grillparzerstr. 10 | ||
| 81675 München | ||
| Germany | ||
| Phone: | +49 (0)89 41 31 38 – 0 | |
| Fax: | +49 (0)89 41 31 38 – 99 | |
| E-mail: | info@wilex.com | |
| Internet: | www.wilex.com | |
| ISIN: | DE0006614720 | |
| WKN: | 661472 | |
| Listed: | Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, München, Stuttgart | |
| End of News | DGAP News-Service |
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