Hi Jan,
bonus points are always good..
I see the resistance where you mentioned
there are some news items available on ZILA, but not that many.. and I am looking more into it
Zila's OraTest Scheduled For FDA Committee Review
PHOENIX, Dec. 3 /PRNewswire/ -- Zila, Inc. (Nasdaq: ZILA - news), international provider of healthcare
products for dental/medical professionals and consumers, announced that the U.S. Food
& Drug Administration's Oncologic Drugs Advisory Committee will review Zila's New Drug Application for its
oral cancer detection system, OraTest®, at a hearing at 1:00 p.m., January 13, 1999, at the Gaithersburg
(Maryland) Holiday Inn.
Zila reported earlier that the FDA accepted the OraTest NDA on September 3, 1998, and assigned it ''priority
review'' status, which targets completion of agency review within six months. ''Priority
review'' is reserved for therapies that may substantially improve the standard of treatment for a certain disease
or condition.
Dr. Ralph Green, President of Zila Biomedical, said, ''We are pleased that the FDA's OraTest review process is
moving this rapidly, and we expect the committee will recommend approval of our inexpensive and potentially
life- saving technology.''
OraTest is a patented 5-minute mouthrinse sequence, used by dentists and physicians to detect early-stage,
asymptomatic lesions and to define margins of lesions for biopsy and surgery. When oral
cancer is detected at advanced stage, which occurs in the majority of cases today, 5-year survival rates are as
low as 18 percent. But with early detection, survival rates exceed 90 percent. OraTest is
available or approved in 13 countries; additional regulatory approvals and distribution agreements are being
pursued worldwide.
Zila, Inc., markets pharmaceutical, biomedical, dental and nutritional products to professionals and consumers
through seven divisions: Zila Biomedical is introducing the OraTest® oral cancer detection system worldwide;
Zila Manufacturing produces the only pharmaceutical-grade toluidine blue - Zila® Tolonium Chloride; Zila
Pharmaceuticals markets prescription and non-prescription oral healthcare products; Zila Dental Supply is a
national dental supplies distributor; PracticeWorks
develops and markets proprietary dental practice management software; Cygnus Imaging manufactures and
markets intraoral video camera and digital x-ray systems; and Oxycal Laboratories manufactures and supplies
Ester-C® vitamin products worldwide. More information is
available at www.zila.com.
This document contains forward-looking statements which are based on Zila's expectations and are subject to
various business risks and uncertainties, some of which are beyond Zila's control. Actual
results could differ materially from these forward-looking statements as a result of such risks. There can be no
assurances that the forward looking statements contained herein will in fact transpire or
prove to be accurate.
SOURCE: Zila, Inc. |
