SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 19, 2001
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EDG Capital, Inc.
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(Exact name of registrant as specified in its charter)
New York 33-37674-NY 11-3023098
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(State or other (IRS Employer
jurisdiction of (Commission File Identification
incorporation) Number) No.)
700 Stewart Avenue, Garden City, New York 11530
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(Address of principal executive offices, zip code)
Registrant's telephone number, including area code: (516) 222-7749
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N/A
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(Former name or former address, if changed since last report)
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Item 5. Other Events.
On January 19, 2001, EDG Capital, Inc. issued a press release announcing
that it has filed an Investigational New Drug (IND) application with the Food
and Drug Administration (FDA) to investigate the use of Colloidal ^32P
Phosphorus and Macroaggregated Albumin (^32P/MAA) in the treatment of solid
tumors.
In November 2000, the FDA performed an inspection of the Center for
Molecular Medicine, the facility where the ^32P/MAA studies are being performed.
The Center for Molecular Medicine is a clinical research group under management
contract with EDG Capital, Inc.'s subsidiary Isotope Solutions, Inc. While the
results of the inspection were favorable, the FDA asked Dr. Stanley Order, the
principal investigator, to file an IND for its review. On November 27, 2000, Dr.
Order filed an IND to permit the use of the ^32P/MAA combination in clinical
studies of pancreatic and brain tumors. Since that time, the FDA has given Dr.
Order permission to continue the studies of ^32P/MAA in pancreatic cancer.
Before enrollment of patients into the brain cancer study can proceed, the FDA
has asked for assurance that the ^32P and MAA products meet a specific purity
requirement (specifically, bacterial endotoxin levels) for use in the brain.
Isotope Solutions, Inc. is currently working with its suppliers to provide
assurance to the FDA that the two products meet the FDA's requirement and
anticipates that the issue will be resolved in the near future.
Item 7. Financial Statements and Exhibits.
(c) Exhibits
99.1 EDG Capital, Inc. Press Release issued January 19, 2001.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
EDG CAPITAL, INC.
Dated: January 19, 2001 By: /s/ Jack Schwartzberg
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Jack Schwartzberg
Chief Executive Officer, President and
Chairman
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