Report on June 16, 2005 AMDL Meeting With U.S. Food and Drug Administration
June 20 2005 - 6:00AM
PR Newswire (US)
Report on June 16, 2005 AMDL Meeting With U.S. Food and Drug
Administration TUSTIN, Calif., June 20 /PRNewswire-FirstCall/ --
AMDL, Inc. (AMEX:ADL), a developer and marketer of tests for the
early detection of cancer and other serious diseases, and its
consultant, Diagnostic Oncology Clinical Research Organization,
(DOCRO) met with the U.S. FDA on June 16, 2005. The purpose of the
meeting was for the FDA to explain its areas of concern on the
recent adjunctive submission and to discuss the appropriate steps
necessary to resolve such concerns. The FDA has requested
additional data from AMDL and DOCRO. Although the Company cannot
predict the length of time required to compile the data requested
by the FDA, AMDL and DOCRO believe this data can be generated from
the clinical samples used in its recent FDA submission. About AMDL
AMDL, Inc. (AMEX:ADL), headquartered in Tustin, California, is a
theranostics company, involved in the detection and treatment of
the same disease, cancer. AMDL is the inventor, developer and
worldwide marketer through exclusive distribution agreements of the
DR-70(R) non-invasive cancer blood test, which has demonstrated its
ability to detect the presence in humans of up to 13 cancers 84
percent of the time overall. In a study published in the Journal of
Immunoassay (1998, vol. 19, pp 63-72) DR-70(R) was shown to detect
at least 13 different types of cancer (lung, breast, stomach,
liver, colon, rectal, ovarian, esophageal, cervical, trophoblastic,
thyroid, malignant lymphoma, pancreatic) although the sample size
for 9 of the cancers was not statistically significant. Clinical
trials of DR-70(R) have been conducted in Canada, China, Germany,
Taiwan and Turkey. DR-70(R) can detect many kinds of cancer using a
single tube of blood, eliminating the need for costly, multiple
tests. AMDL also owns a combination immunogene therapy technology
that is a possible treatment for those already diagnosed with
cancer and could eventually be used as a vaccine to protect
patients known to be at risk because of a family history for
certain types of cancer. The combination therapy both builds the
body's immune system and destroys cancer cells. More information
about AMDL and its additional products can be obtained at
http://www.amdl.com/. Forward-Looking Statements Statements in this
press release may constitute forward-looking statements and are
subject to numerous risks and uncertainties, including the failure
to complete successfully the development of new or enhanced
products, the Company's future capital needs, the lack of market
demand for any new or enhanced products the Company may develop,
any actions by the Company's partners that may be adverse to the
Company, the success of competitive products, other economic
factors affecting the Company and its markets, and other risks
detailed from time to time in the Company's filings with the
Securities and Exchange Commission. The actual results may differ
materially from those contained in this press release. The Company
disclaims any obligation to update any statements in this press
release. Contact: AMDL, Inc. Gary L. Dreher President & CEO
(714) 505-4460 DATASOURCE: AMDL, Inc. CONTACT: Gary L. Dreher,
President & CEO of AMDL, Inc., +1-714-505-4460 Web site:
http://www.amdl.com/
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